Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-26 @ 1:25 AM
Study NCT ID:
NCT01512004
Status:
COMPLETED
Last Update Posted:
2012-01-25
First Post:
2010-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015586', 'term': 'propiverine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2010-11-24', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record', 'timeFrame': 'prior to medication and 8 weeks after medication', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record', 'timeFrame': 'prior to medication, 2 weeks and 8 weeks after medication', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'urgent micturition', 'frequent micturition', 'urge urinary incontinence'], 'conditions': ['Overactive Bladder']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 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\n* Mean volume of single micturition is less than 200ml by micturition diary dard during screening period\n* The subject is willing and able to complete the micturition diary card correctly\n* Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form\n\nExclusion Criteria:\n\n* Confirmed by the investigator that subject has severe stress incontinence.\n* Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.\n* Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.\n* Subject who has a symptomatic acute urinary tract infection.\n* Subject who has a recurrent urinary tract infection.\n* Subject who has interstitial cystitis.\n* Subject who has an agnogenic hematuria.\n* Subject who has a bladder outlet obstruction of clinical significance.\n* Subject who needs retention catheterization or intermittent catheterization.\n* Patient with malignant tumor.\n* Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.\n* Subject 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.\n* Women 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."}, 'identificationModule': {'nctId': 'NCT01512004', 'briefTitle': 'Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, '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', 'orgStudyIdInfo': {'id': 'LEES-MIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propiverine Hydrochloride Extended-Release Capsule', 'description': '30 mg/capsule; oral; once per day', 'interventionNames': ['Drug: Propiverine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Tolterodine Extended-release Tablet', 'description': '4mg/tablet; oral; once per day', 'interventionNames': ['Drug: Tolterodine Extended-release Tablet']}], 'interventions': [{'name': 'Propiverine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Mictonorm', 'Propierine Hydrochloride Extended-Release Capsule'], 'description': 'drug of oral capsule', 'armGroupLabels': ['Propiverine Hydrochloride Extended-Release Capsule']}, {'name': 'Tolterodine Extended-release Tablet', 'type': 'DRUG', 'description': '4mg/tablet; oral; once per day', 'armGroupLabels': ['Tolterodine Extended-release Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Benjamin Li, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Lee's Pharmaceutical"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'APOGEPHA Arzneimittel GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}