{ "FullStudy":{ "Rank":217986, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514240", "OrgStudyIdInfo":{ "OrgStudyId":"D9423C00001" }, "Organization":{ "OrgFullName":"AstraZeneca", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan", "OfficialTitle":"A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan" }, "StatusModule":{ "StatusVerifiedDate":"September 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 4, 2015", "ResultsFirstSubmitQCDate":"September 8, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 31, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 8, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 31, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"AstraZeneca", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.", "DetailedDescription":"A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Crohn's Disease" ] }, "KeywordList":{ "Keyword":[ "mild to moderate active Crohn's disease", "affecting ileum", "ileocecal region", "ascending colon", "score of 180-400 on the CDAI" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"123", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"D9421-C", "ArmGroupType":"Experimental", "ArmGroupDescription":"D9421-C 9 mg once daily", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: D9421-C capsule 3 mg" ] } },{ "ArmGroupLabel":"Mesalazine", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Mesalazine 1 g three times a day", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Mesalazine tablets" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"D9421-C capsule 3 mg", "InterventionDescription":"Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "D9421-C" ] } },{ "InterventionType":"Drug", "InterventionName":"Mesalazine tablets", "InterventionDescription":"Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mesalazine" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Remission After 8-week of Treatment", "PrimaryOutcomeDescription":"For the primary efficacy variable \"Remission after 8 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.", "PrimaryOutcomeTimeFrame":"8 Week" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Remission After 2-week of Treatment", "SecondaryOutcomeDescription":"For the secondary efficacy variable \"Remission after 2 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Remission After 4-week of Treatment", "SecondaryOutcomeDescription":"For the secondary efficacy variable \"Remission after 4 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in Observed CDAI Scores From Baseline to Weeks 2", "SecondaryOutcomeDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in Observed CDAI Scores From Baseline to Weeks 4", "SecondaryOutcomeDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in Observed CDAI Scores From Baseline to Weeks 8", "SecondaryOutcomeDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Cumulative Remission Rate at Week 2", "SecondaryOutcomeDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Cumulative Remission Rate at Week 4", "SecondaryOutcomeDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Cumulative Remission Rate at Week 8", "SecondaryOutcomeDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8", "SecondaryOutcomeDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in Total IBDQ Scores From Baseline to Weeks 2", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in Total IBDQ Scores From Baseline to Weeks 4", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in Total IBDQ Scores From Baseline to Weeks 8", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in Total IBDQ Scores From Baseline to Weeks 10", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"10 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"10 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"10 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"10 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 2 - Social Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"2 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 4 - Social Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"4 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 8 - Social Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"8 Week" },{ "SecondaryOutcomeMeasure":"Change in IBDQ Scores From Baseline to Weeks 10 - Social Function", "SecondaryOutcomeDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "SecondaryOutcomeTimeFrame":"10 Week" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n15 years of age or older\nMain active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation\nAbility to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline\n\nExclusion Criteria:\n\nPatient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)\nPatient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug\nPatient who need any medication which is prohibited due to suspected influence to metabolism of the study drug\nPatient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"15 Years", "MaximumAge":"130 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Toshifumi Hibi, Professor, Chairman", "OverallOfficialAffiliation":"Department of Internal Medicine, Keio University School of Medicine", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Chikushino-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Fukuoka-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Fukuyama-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Hirosaki-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Hiroshima-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Kagoshima-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Kitakyushu-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Koshigaya-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Kurume-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Kyoto-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Nagakute-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Nagoya-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Nishinomiya-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Oita-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Okayama-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Omura-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Osaka-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Osaka", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Sakura", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Sapporo-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Sendai-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Shinjyuku-ku", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Suginami-ku", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Suita-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Toyoake-shi", "LocationCountry":"Japan" },{ "LocationFacility":"Research Site", "LocationCity":"Toyota-shi", "LocationCountry":"Japan" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Out of 123 enrolled subjects, 112 subjects were randomised and 11 subjects were not randomised. The reasons of no randomisation were 'Eligibility criteria not met' (9 subjects) and 'Adverse event' (2 subjects).", "FlowRecruitmentDetails":"First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "FlowGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Mesalazine 3g + D9421-C Placebo", "FlowGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"56" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"56" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"45" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"11" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Subject Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"7" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "BaselineGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Mesalazine 3g + D9421-C Placebo", "BaselineGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"56" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"56" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"112" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"38.1", "BaselineMeasurementSpread":"13.43", "BaselineMeasurementLowerLimit":"16", "BaselineMeasurementUpperLimit":"77" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"35.8", "BaselineMeasurementSpread":"10.71", "BaselineMeasurementLowerLimit":"19", "BaselineMeasurementUpperLimit":"64" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"36.9", "BaselineMeasurementSpread":"12.15", "BaselineMeasurementLowerLimit":"16", "BaselineMeasurementUpperLimit":"77" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"<30 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"39" } ] } } ] } },{ "BaselineClassTitle":">=30 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"36" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"73" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"43" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"80" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Asian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"56" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"111" } ] } } ] } },{ "BaselineClassTitle":"Black/African American", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Remission After 8-week of Treatment", "OutcomeMeasureDescription":"For the primary efficacy variable \"Remission after 8 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.", "OutcomeAnalysisTestedNonInferiority":"Yes", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than –10% in FAS Population.", "OutcomeAnalysisPValue":"0.526", "OutcomeAnalysisStatisticalMethod":"Chi-squared", "OutcomeAnalysisParamType":"Difference of proportion", "OutcomeAnalysisParamValue":"5.4", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-8.49", "OutcomeAnalysisCIUpperLimit":"18.94" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Remission After 2-week of Treatment", "OutcomeMeasureDescription":"For the secondary efficacy variable \"Remission after 2 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.768", "OutcomeAnalysisStatisticalMethod":"Chi-squared", "OutcomeAnalysisParamType":"Difference of proportion", "OutcomeAnalysisParamValue":"1.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-8.54", "OutcomeAnalysisCIUpperLimit":"12.15", "OutcomeAnalysisEstimateComment":"Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Remission After 4-week of Treatment", "OutcomeMeasureDescription":"For the secondary efficacy variable \"Remission after 4 weeks of treatment\", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.208", "OutcomeAnalysisStatisticalMethod":"Chi-squared", "OutcomeAnalysisParamType":"Difference of proportion", "OutcomeAnalysisParamValue":"8.9", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.87", "OutcomeAnalysisCIUpperLimit":"20.58", "OutcomeAnalysisEstimateComment":"Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Observed CDAI Scores From Baseline to Weeks 2", "OutcomeMeasureDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-38.5", "OutcomeMeasurementSpread":"8.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-15.7", "OutcomeMeasurementSpread":"7.66" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.058", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"-22.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-42.55", "OutcomeAnalysisCIUpperLimit":"-3.09", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"11.89", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Observed CDAI Scores From Baseline to Weeks 4", "OutcomeMeasureDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-58.7", "OutcomeMeasurementSpread":"9.44" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-28.7", "OutcomeMeasurementSpread":"7.29" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.014", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"-30.0", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-49.95", "OutcomeAnalysisCIUpperLimit":"-9.96", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"12.05", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Observed CDAI Scores From Baseline to Weeks 8", "OutcomeMeasureDescription":"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.\n\nPatients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"51" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-67.0", "OutcomeMeasurementSpread":"11.17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-45.7", "OutcomeMeasurementSpread":"9.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.144", "OutcomeAnalysisStatisticalMethod":"Mixed Models Analysis", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"-21.4", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-45.47", "OutcomeAnalysisCIUpperLimit":"2.74", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"14.53", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Cumulative Remission Rate at Week 2", "OutcomeMeasureDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.5", "OutcomeMeasurementLowerLimit":"5.23", "OutcomeMeasurementUpperLimit":"19.77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.7", "OutcomeMeasurementLowerLimit":"3.92", "OutcomeMeasurementUpperLimit":"17.51" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Cumulative Remission Rate at Week 4", "OutcomeMeasureDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25.0", "OutcomeMeasurementLowerLimit":"15.48", "OutcomeMeasurementUpperLimit":"34.52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17.9", "OutcomeMeasurementLowerLimit":"9.44", "OutcomeMeasurementUpperLimit":"26.28" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Cumulative Remission Rate at Week 8", "OutcomeMeasureDescription":"Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37.5", "OutcomeMeasurementLowerLimit":"26.86", "OutcomeMeasurementUpperLimit":"48.14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"30.4", "OutcomeMeasurementLowerLimit":"20.25", "OutcomeMeasurementUpperLimit":"40.46" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"14.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.50", "OutcomeAnalysisCIUpperLimit":"27.40", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"16.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.66", "OutcomeAnalysisCIUpperLimit":"29.61", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"27", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"16.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.85", "OutcomeAnalysisCIUpperLimit":"30.29", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"7.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-5.67", "OutcomeAnalysisCIUpperLimit":"19.71", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"14.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.50", "OutcomeAnalysisCIUpperLimit":"27.40", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8", "OutcomeMeasureDescription":"Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"56" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24", "OutcomeMeasurementSpread":"9.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17", "OutcomeMeasurementSpread":"7.46" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference of proportions", "OutcomeAnalysisParamValue":"12.5", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.44", "OutcomeAnalysisCIUpperLimit":"26.68", "OutcomeAnalysisEstimateComment":"90% CI calculated using the Newcombe-Wilson score method without continuity corrections." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Total IBDQ Scores From Baseline to Weeks 2", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"54" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.2", "OutcomeMeasurementSpread":"2.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementSpread":"2.41" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"10.5", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"4.86", "OutcomeAnalysisCIUpperLimit":"16.14", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"3.40", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Total IBDQ Scores From Baseline to Weeks 4", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19.4", "OutcomeMeasurementSpread":"3.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.8", "OutcomeMeasurementSpread":"2.44" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"12.6", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"6.07", "OutcomeAnalysisCIUpperLimit":"19.11", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"3.93", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Total IBDQ Scores From Baseline to Weeks 8", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"51" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.3", "OutcomeMeasurementSpread":"2.93" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.8", "OutcomeMeasurementSpread":"3.16" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"12.6", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"5.40", "OutcomeAnalysisCIUpperLimit":"19.72", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"4.31", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Total IBDQ Scores From Baseline to Weeks 10", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"10 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21.1", "OutcomeMeasurementSpread":"3.11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementSpread":"2.96" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"14.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"6.90", "OutcomeAnalysisCIUpperLimit":"21.23", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"4.32", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"54" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.1", "OutcomeMeasurementSpread":"0.77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.7", "OutcomeMeasurementSpread":"0.82" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"3.4", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.49", "OutcomeAnalysisCIUpperLimit":"5.29", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.14", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.6", "OutcomeMeasurementSpread":"0.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.8", "OutcomeMeasurementSpread":"0.84" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"3.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.64", "OutcomeAnalysisCIUpperLimit":"5.97", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.31", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"51" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"1.04" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.4", "OutcomeMeasurementSpread":"1.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"4.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.58", "OutcomeAnalysisCIUpperLimit":"6.64", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.53", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"10 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.9", "OutcomeMeasurementSpread":"1.08" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.6", "OutcomeMeasurementSpread":"0.98" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"3.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.90", "OutcomeAnalysisCIUpperLimit":"5.76", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.47", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"54" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.0", "OutcomeMeasurementSpread":"0.49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.0", "OutcomeMeasurementSpread":"0.48" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"2.0", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.89", "OutcomeAnalysisCIUpperLimit":"3.17", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.69", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. 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The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. 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The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. 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The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. 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The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"10 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.0", "OutcomeMeasurementSpread":"1.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.3", "OutcomeMeasurementSpread":"1.34" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"6.6", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"3.56", "OutcomeAnalysisCIUpperLimit":"9.72", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.86", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 2 - Social Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"2 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"56" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"54" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementSpread":"0.45" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.6", "OutcomeMeasurementSpread":"0.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"1.2", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.01", "OutcomeAnalysisCIUpperLimit":"2.43", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.73", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 4 - Social Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"4 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.5", "OutcomeMeasurementSpread":"0.58" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.7", "OutcomeMeasurementSpread":"0.56" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"1.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.42", "OutcomeAnalysisCIUpperLimit":"3.12", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.81", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 8 - Social Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"8 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"51" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.3", "OutcomeMeasurementSpread":"0.57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.7", "OutcomeMeasurementSpread":"0.63" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"1.6", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.19", "OutcomeAnalysisCIUpperLimit":"3.04", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.86", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in IBDQ Scores From Baseline to Weeks 10 - Social Function", "OutcomeMeasureDescription":"The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.", "OutcomeMeasurePopulationDescription":"All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"10 Week", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "OutcomeGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Mesalazine 3g + D9421-C Placebo", "OutcomeGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.4", "OutcomeMeasurementSpread":"0.63" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementSpread":"0.56" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference between group", "OutcomeAnalysisParamValue":"1.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.15", "OutcomeAnalysisCIUpperLimit":"2.76", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.85", "OutcomeAnalysisEstimateComment":"The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group." } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"D9421-C 9mg + Mesalazine Placebo", "EventGroupDescription":"Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"56", "EventGroupOtherNumAffected":"11", "EventGroupOtherNumAtRisk":"56" },{ "EventGroupId":"EG001", "EventGroupTitle":"Mesalazine 3g + D9421-C Placebo", "EventGroupDescription":"Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"56", "EventGroupOtherNumAffected":"16", "EventGroupOtherNumAtRisk":"56" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Ileus", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"56" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"56" } ] } },{ "SeriousEventTerm":"Lower gastrointestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"56" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"56" } ] } },{ "SeriousEventTerm":"Pneumatosis intestinalis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"56" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"56" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Crohn's disease", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 17.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"56" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"56" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 17.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"56" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"56" } ] } },{ "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 17.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"56" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"10", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"56" } ] } },{ "OtherEventTerm":"Pharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 17.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"56" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"56" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA 17.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"56" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"56" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed." }, "PointOfContact":{ "PointOfContactTitle":"Masahiro Nii", "PointOfContactOrganization":"Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan", "PointOfContactEMail":"Masahiro.Nii@astrazeneca.com" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000019804", "InterventionMeshTerm":"Mesalamine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M20281", "InterventionBrowseLeafName":"Mesalamine", "InterventionBrowseLeafAsFound":"Mesalazine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", 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"ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003424", "ConditionMeshTerm":"Crohn Disease" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000015212", "ConditionAncestorTerm":"Inflammatory Bowel Diseases" },{ "ConditionAncestorId":"D000005759", "ConditionAncestorTerm":"Gastroenteritis" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5221", "ConditionBrowseLeafName":"Crohn Disease", "ConditionBrowseLeafAsFound":"Crohn's Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16500", "ConditionBrowseLeafName":"Inflammatory Bowel Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7458", "ConditionBrowseLeafName":"Gastroenteritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }