{ "FullStudy":{ "Rank":218017, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513811", "OrgStudyIdInfo":{ "OrgStudyId":"rjyyxhk0906" }, "Organization":{ "OrgFullName":"Shanghai Jiao Tong University School of Medicine", "OrgClass":"OTHER" }, "BriefTitle":"Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective", "OfficialTitle":"High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation" }, "StatusModule":{ "StatusVerifiedDate":"April 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 17, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Xiaobo Li", "ResponsiblePartyInvestigatorTitle":"Xiaobo Li", "ResponsiblePartyInvestigatorAffiliation":"Shanghai Jiao Tong University School of Medicine" }, "LeadSponsor":{ "LeadSponsorName":"Shanghai Jiao Tong University School of Medicine", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However, a significant number of patients, especially those constipated patients, failed colonoscopies due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions. The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis, shorten colonic transit time and accelerate propulsion of colonic luminal contents through inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to determine the efficacy, tolerance and safety of high dose of itopride, when given in different times before administration of PEG-E, for colonic preparation in patients with chronic constipation.", "DetailedDescription":"Colonoscopy is a reliable procedure for the investigation of colonic and distal terminal ileum disease. The diagnostic accuracy of colonoscopy is dependent on visualization of the colonic mucosa; hence an appropriate bowel preparation is essential for the examination. Despite multiple lavage were used throughout the years, the suboptimal cleaning level have been reported vary from 10% to more than 20% and up to one-third of incomplete or failed colonoscopies can be ascribed to poor bowel preparation. So it is important for us to search a new regimen for bowel preparation." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Constipation" ] }, "KeywordList":{ "Keyword":[ "bowel preparation", "constipation", "polyethylene glycol", "itopride" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"115", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"group PEG", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"This group is set as a control group and received 2 packets of Polyethylene glycol electrolyte solutions on the morning of the examination day as us we usually done.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Polyethylene glycol electrolyte solutions" ] } },{ "ArmGroupLabel":"group PEG+Itp", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Itopride and Polyethylene glycol electrolyte solutions" ] } },{ "ArmGroupLabel":"group PEG+4Itp", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: itopride and polyethylene glycol electrolyte solutions" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Polyethylene glycol electrolyte solutions", "InterventionDescription":"Patients received 2 packets of polyethylene glycol electrolyte solutions(PEG-E) without itopride.PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours.6 hours later, the colonoscopy was performed.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "group PEG" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "PEG-E" ] } },{ "InterventionType":"Drug", "InterventionName":"Itopride and Polyethylene glycol electrolyte solutions", "InterventionDescription":"Patients were assigned to itopride 150mg, then 30 min later they were given 2 packets of polyethylene glycol electrolyte solutions(PEG-E). PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopy was performed.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "group PEG+Itp" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "PEG-E", "Itopride hydrochloride" ] } },{ "InterventionType":"Drug", "InterventionName":"itopride and polyethylene glycol electrolyte solutions", "InterventionDescription":"Patients received itopride 150mg t.i.d(7am、12am、8pm) 24 hours before the examination day and another 150mg 30min before administration of polyethylene glycol electrolyte solutions(PEG-E).Two packets of PEG-E were dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min and consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopies were performed.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "group PEG+4Itp" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "PEG-E", "itopride hydrochloride" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"the quality of bowel preparation", "PrimaryOutcomeDescription":"the Boston Bowel Preparation Scale (BBPS): the colon was divided into 3 broad segments: the right side (the cecum and ascending colon), the middle section (the hepatic flexures, transverse colon and splenic flexures), and the left side of the colon (the descending colon, sigmoid colon, and rectum). Each region of the colon receives a score from 0 to 3 as summarized in table 1, score 0 was considered poor preparation while score 3 indicated good cleaning quality. And these segment scores are summed for a total BBPS score ranged from 0 to 9.", "PrimaryOutcomeTimeFrame":"the day of colonoscopy examination" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"intestinal bubble scale", "SecondaryOutcomeDescription":"The scores of intestinal bubble were categorized into three levels: 0, no or nearly no bubble present; 1, small amounts of bubbles that could be washed away easily; 2, multiple collections of bubbles that could be washed away with volumes of water.", "SecondaryOutcomeTimeFrame":"the day of colonoscopy examination" },{ "SecondaryOutcomeMeasure":"time of examination", "SecondaryOutcomeDescription":"Time of examination includes caecal intubation time and withdrawal time. Caecal intubation time defined as the time passing the colonoscope to the ileocaecal valve. Withdrawal time defined as the time withdrawing from ileocaecal junction to anus.", "SecondaryOutcomeTimeFrame":"the day of examination" },{ "SecondaryOutcomeMeasure":"times of defecation", "SecondaryOutcomeDescription":"The times of defecation during the preparation were obtained and analyzed.", "SecondaryOutcomeTimeFrame":"the day before and the day of examination" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients suspected colonic disease and suffered from chronic constipation were referred for colonoscopy and enrolled in the study. Chronic constipation was diagnosed on the basis of Rome III criteria.Suspected colonic disease was defined as:\n\nrecent change of bowel habits;\nobscure GI bleeding (hemafecia, melena or positive fecal occult blood test);\nobscure abdominal pain;\nweight loss;\npositive findings in the colon on GI imaging;\nserological test referred to colorectal cancer such as CEA elevated obviously;\nfamily history of colorectal cancer or adenomatous polyps.\n\nExclusion Criteria:\n\nusage of prokinetic agents such as itopride, mosapride within 4 weeks and tricyclic antidepressants 8 weeks prior to entering the protocol;\nknown allergies or other contraindication to PEG or itopride;\na history of abdominal surgery or bowel obstruction;\npregnant or lactating;\nconditions associated with severe cardiac, hepatic, or renal impairment.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Li X B, M.D., Ph.D.", "OverallOfficialAffiliation":"Shanghai Jiao-Tong University School of Medicine Renji Hospital", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Shanghai Jiao-Tong University School of Medicine Renji Hospital", "LocationCity":"Shanghai", "LocationState":"Shanghai", "LocationZip":"200001", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000019999", "InterventionMeshTerm":"Pharmaceutical Solutions" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M20444", "InterventionBrowseLeafName":"Pharmaceutical Solutions", "InterventionBrowseLeafAsFound":"Solution", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003248", "ConditionMeshTerm":"Constipation" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012817", "ConditionAncestorTerm":"Signs and Symptoms, Digestive" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5055", "ConditionBrowseLeafName":"Constipation", "ConditionBrowseLeafAsFound":"Constipation", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14205", "ConditionBrowseLeafName":"Signs and Symptoms, Digestive", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }