{ "FullStudy":{ "Rank":217678, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518257", "OrgStudyIdInfo":{ "OrgStudyId":"191622-102" }, "Organization":{ "OrgFullName":"Allergan", "OrgClass":"INDUSTRY" }, "BriefTitle":"Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain" }, "StatusModule":{ "StatusVerifiedDate":"July 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 15, 2014", "ResultsFirstSubmitQCDate":"July 15, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"August 7, 2014", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"January 27, 2014", "DispFirstSubmitQCDate":"January 27, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"February 27, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 15, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 7, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Allergan", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Osteoarthritis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"121", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"botulinum toxin Type A", "ArmGroupType":"Experimental", "ArmGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: botulinum toxin Type A" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Normal Saline" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"botulinum toxin Type A", "InterventionDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "botulinum toxin Type A" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "BOTOX®" ] } },{ "InterventionType":"Drug", "InterventionName":"Normal Saline", "InterventionDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4", "PrimaryOutcomeDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "PrimaryOutcomeTimeFrame":"Baseline, Week 4" },{ "PrimaryOutcomeMeasure":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8", "PrimaryOutcomeDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "PrimaryOutcomeTimeFrame":"Baseline, Week 8" },{ "PrimaryOutcomeMeasure":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12", "PrimaryOutcomeDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "PrimaryOutcomeTimeFrame":"Baseline, Week 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score", "SecondaryOutcomeDescription":"The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.", "SecondaryOutcomeTimeFrame":"Baseline, Week 8" },{ "SecondaryOutcomeMeasure":"Change From Baseline in WOMAC Pain Score", "SecondaryOutcomeDescription":"The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.", "SecondaryOutcomeTimeFrame":"Baseline, Week 8" },{ "SecondaryOutcomeMeasure":"Change From Baseline in WOMAC Physical Function Score", "SecondaryOutcomeDescription":"The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.", "SecondaryOutcomeTimeFrame":"Baseline, Week 8" },{ "SecondaryOutcomeMeasure":"Patient Global Impression of Change Score", "SecondaryOutcomeDescription":"The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.", "SecondaryOutcomeTimeFrame":"Week 8" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPainful osteoarthritis in the study knee\nAble to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study\n\nExclusion Criteria:\n\nChronic pain conditions other than knee osteoarthritis\nPresence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year\nSurgery to the study knee within 24 weeks\nTreatment with hyaluronic acid in the study knee within 24 weeks\nTreatment with corticosteroids in the study knee within 12 weeks\nDiagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis\nPrevious treatment with botulinum toxin of any serotype for any reason", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Allergan", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Aalborg", "LocationCountry":"Denmark" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Botulinum Toxin Type A", "FlowGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"61" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"60" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"59" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"60" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other Miscellaneous Reason", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Botulinum Toxin Type A", "BaselineGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"60" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"121" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"40 to 64 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"61" } ] } } ] } },{ "BaselineClassTitle":"≥ 65 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"62" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"59" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4", "OutcomeMeasureDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 4", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementSpread":"1.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"1.28" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.8", "OutcomeMeasurementSpread":"1.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.8", "OutcomeMeasurementSpread":"1.87" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score", "OutcomeMeasureDescription":"The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"104.5", "OutcomeMeasurementSpread":"36.53" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"107.6", "OutcomeMeasurementSpread":"37.44" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8 (n=59,59)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-46.5", "OutcomeMeasurementSpread":"35.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-43.8", "OutcomeMeasurementSpread":"47.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in WOMAC Pain Score", "OutcomeMeasureDescription":"The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"23.9", "OutcomeMeasurementSpread":"6.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24.3", "OutcomeMeasurementSpread":"7.01" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8 (n=59,59)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-10.7", "OutcomeMeasurementSpread":"7.27" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-11.0", "OutcomeMeasurementSpread":"9.75" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in WOMAC Physical Function Score", "OutcomeMeasureDescription":"The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"71.0", "OutcomeMeasurementSpread":"28.43" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"73.3", "OutcomeMeasurementSpread":"29.77" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8 (n=59,59 )", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-31.7", "OutcomeMeasurementSpread":"26.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-28.6", "OutcomeMeasurementSpread":"35.26" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Patient Global Impression of Change Score", "OutcomeMeasureDescription":"The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.", "OutcomeMeasurePopulationDescription":"Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"59" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"59" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.3", "OutcomeMeasurementSpread":"1.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.0", "OutcomeMeasurementSpread":"1.38" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8", "OutcomeMeasureDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementSpread":"1.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"1.28" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.2", "OutcomeMeasurementSpread":"1.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.3", "OutcomeMeasurementSpread":"2.15" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12", "OutcomeMeasureDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Safety population included all treated participants based on the actual treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementSpread":"1.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"1.28" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.2", "OutcomeMeasurementSpread":"1.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.5", "OutcomeMeasurementSpread":"2.24" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group", "OutcomeMeasureDescription":"The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Weeks 4, 8 and 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"36" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementSpread":"1.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.4", "OutcomeMeasurementSpread":"1.35" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.9", "OutcomeMeasurementSpread":"1.56" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.5", "OutcomeMeasurementSpread":"1.58" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.6", "OutcomeMeasurementSpread":"2.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.8", "OutcomeMeasurementSpread":"2.01" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.6", "OutcomeMeasurementSpread":"1.79" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.0", "OutcomeMeasurementSpread":"2.27" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group", "OutcomeMeasureDescription":"The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.", "OutcomeMeasurePopulationDescription":"Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on a scale", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Botulinum Toxin Type A", "OutcomeGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"36" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.7", "OutcomeMeasurementSpread":"5.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"22.9", "OutcomeMeasurementSpread":"6.98" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at Week 8 (n=35,31)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-11.0", "OutcomeMeasurementSpread":"7.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-7.5", "OutcomeMeasurementSpread":"9.00" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Botulinum Toxin Type A", "EventGroupDescription":"A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"61", "EventGroupOtherNumAffected":"7", "EventGroupOtherNumAtRisk":"61" },{ "EventGroupId":"EG001", "EventGroupTitle":"Placebo", "EventGroupDescription":"A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"60", "EventGroupOtherNumAffected":"14", "EventGroupOtherNumAtRisk":"60" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Cerebrovascular accident", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA (15.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"61" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"60" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"60" } ] } },{ "OtherEventTerm":"Osteoarthritis", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"60" } ] } },{ "OtherEventTerm":"Arthralgia", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"61" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"60" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo." }, "PointOfContact":{ "PointOfContactTitle":"Therapeutic Area Head,", "PointOfContactOrganization":"Allergan, Inc", "PointOfContactEMail":"clinicaltrials@allergan.com", "PointOfContactPhone":"714-246-4500" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001905", "InterventionMeshTerm":"Botulinum Toxins" },{ "InterventionMeshId":"D000019274", "InterventionMeshTerm":"Botulinum Toxins, Type A" },{ "InterventionMeshId":"C000542869", "InterventionMeshTerm":"abobotulinumtoxinA" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000065087", "InterventionAncestorTerm":"Acetylcholine Release Inhibitors" },{ "InterventionAncestorId":"D000049990", "InterventionAncestorTerm":"Membrane Transport Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000018678", "InterventionAncestorTerm":"Cholinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000009465", "InterventionAncestorTerm":"Neuromuscular Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M19841", "InterventionBrowseLeafName":"Botulinum Toxins, Type A", "InterventionBrowseLeafAsFound":"Botulinum toxin type A", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M258543", "InterventionBrowseLeafName":"abobotulinumtoxinA", "InterventionBrowseLeafAsFound":"Botulinum toxin type A", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3765", "InterventionBrowseLeafName":"Botulinum Toxins", "InterventionBrowseLeafAsFound":"Botulinum toxin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2054", "InterventionBrowseLeafName":"Acetylcholine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19342", "InterventionBrowseLeafName":"Cholinergic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010003", "ConditionMeshTerm":"Osteoarthritis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001168", "ConditionAncestorTerm":"Arthritis" },{ "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000012216", "ConditionAncestorTerm":"Rheumatic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11509", "ConditionBrowseLeafName":"Osteoarthritis", "ConditionBrowseLeafAsFound":"Osteoarthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20752", "ConditionBrowseLeafName":"Osteoarthritis, Knee", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3057", "ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }