{ "FullStudy":{ "Rank":218156, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512004", "OrgStudyIdInfo":{ "OrgStudyId":"LEES-MIC" }, "Organization":{ "OrgFullName":"Lee's Pharmaceutical Limited", "OrgClass":"INDUSTRY" }, "BriefTitle":"Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder", "OfficialTitle":"Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 24, 2010", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Lee's Pharmaceutical Limited", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"APOGEPHA Arzneimittel GmbH", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.", "DetailedDescription":"This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Overactive Bladder" ] }, "KeywordList":{ "Keyword":[ "Overactive Bladder", "urgent micturition", "frequent micturition", "urge urinary incontinence" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"324", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Propiverine Hydrochloride Extended-Release Capsule", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"30 mg/capsule; oral; once per day", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Propiverine Hydrochloride" ] } },{ "ArmGroupLabel":"Tolterodine Extended-release Tablet", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"4mg/tablet; oral; once per day", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tolterodine Extended-release Tablet" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Propiverine Hydrochloride", "InterventionDescription":"drug of oral capsule", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Propiverine Hydrochloride Extended-Release Capsule" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Mictonorm", "Propierine Hydrochloride Extended-Release Capsule" ] } },{ "InterventionType":"Drug", "InterventionName":"Tolterodine Extended-release Tablet", "InterventionDescription":"4mg/tablet; oral; once per day", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tolterodine Extended-release Tablet" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record", "PrimaryOutcomeDescription":"The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication", "PrimaryOutcomeTimeFrame":"prior to medication and 8 weeks after medication" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record", "SecondaryOutcomeDescription":"The alteration of mean incontinence frequency, mean micturition frequency and volume within 24 hous on the basis of continuous 3-day record,prior to medication, 2 weeks and 8 weeks after medication. Additionaly, to evaluate the subject's feeling of treatment benefit and the time of the drug effect onset.", "SecondaryOutcomeTimeFrame":"prior to medication, 2 weeks and 8 weeks after medication" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period\nMean volume of single micturition is less than 200ml by micturition diary dard during screening period\nThe subject is willing and able to complete the micturition diary card correctly\nSubject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form\n\nExclusion Criteria:\n\nConfirmed by the investigator that subject has severe stress incontinence.\nSubject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.\nSubject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.\nSubject who has a symptomatic acute urinary tract infection.\nSubject who has a recurrent urinary tract infection.\nSubject who has interstitial cystitis.\nSubject who has an agnogenic hematuria.\nSubject who has a bladder outlet obstruction of clinical significance.\nSubject who needs retention catheterization or intermittent catheterization.\nPatient with malignant tumor.\nSubject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.\nSubject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.\nWomen of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Benjamin Li, PhD", "OverallOfficialAffiliation":"Lee's Pharmaceutical", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Beijing Chaoyang Hospital", "LocationCity":"Beijing", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068737", "InterventionMeshTerm":"Tolterodine Tartrate" },{ "InterventionMeshId":"C000015586", "InterventionMeshTerm":"Propiverine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000018727", "InterventionAncestorTerm":"Muscarinic Antagonists" },{ "InterventionAncestorId":"D000018680", "InterventionAncestorTerm":"Cholinergic Antagonists" },{ "InterventionAncestorId":"D000018678", "InterventionAncestorTerm":"Cholinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000064804", "InterventionAncestorTerm":"Urological Agents" },{ "InterventionAncestorId":"D000010276", "InterventionAncestorTerm":"Parasympatholytics" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M300", "InterventionBrowseLeafName":"Tolterodine Tartrate", "InterventionBrowseLeafAsFound":"Tolterodine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M235708", "InterventionBrowseLeafName":"Propiverine", "InterventionBrowseLeafAsFound":"Propiverine hydrochloride", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M19385", "InterventionBrowseLeafName":"Muscarinic Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19344", "InterventionBrowseLeafName":"Cholinergic Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19342", "InterventionBrowseLeafName":"Cholinergic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M11772", "InterventionBrowseLeafName":"Parasympatholytics", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Urol", "InterventionBrowseBranchName":"Urological Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000053201", "ConditionMeshTerm":"Urinary Bladder, Overactive" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014570", "ConditionAncestorTerm":"Urologic Diseases" },{ "ConditionAncestorId":"D000059411", "ConditionAncestorTerm":"Lower Urinary Tract Symptoms" },{ "ConditionAncestorId":"D000020924", "ConditionAncestorTerm":"Urological Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000001745", "ConditionAncestorTerm":"Urinary Bladder Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M25754", "ConditionBrowseLeafName":"Urinary Bladder, Overactive", "ConditionBrowseLeafAsFound":"Overactive Bladder", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15882", "ConditionBrowseLeafName":"Urinary Incontinence", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6519", "ConditionBrowseLeafName":"Enuresis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M25755", "ConditionBrowseLeafName":"Urinary Incontinence, Urge", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15902", "ConditionBrowseLeafName":"Urologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M28051", "ConditionBrowseLeafName":"Lower Urinary Tract Symptoms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21243", "ConditionBrowseLeafName":"Urological Manifestations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3608", "ConditionBrowseLeafName":"Urinary Bladder Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" } ] } } } } } }