Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 12:58 PM
Study NCT ID:
NCT00368706
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], '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': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-09', 'studyFirstSubmitDate': '2006-08-24', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean number of micturitions per 24 hours', 'timeFrame': '8 Weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean volume voided per micturition', 'timeFrame': '8 Weeks'}, {'measure': 'Change from baseline in mean number of incontinence episodes per 24 hours', 'timeFrame': '8 Weeks'}, {'measure': 'Change from baseline in mean urgency frequency per 24 hours', 'timeFrame': '8 Weeks'}, {'measure': 'Change from baseline in mean nocturia episodes per 24 hours', 'timeFrame': '8 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['solifenacin', 'Overactive bladder', 'Urinary incontinence', 'Treatment outcomes', 'VESIcare'], 'conditions': ['Urinary Bladder, Overactive']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients willing and able to complete the micturition diary correctly\n* Patients experiencing frequency of micturition as verified in the diary\n* Patients experiencing significant post void residual volume\n* OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.\n\nExclusion Criteria:\n\n* Significant post void residual volume\n* Patients with indwelling catheters or practicing intermittent self- catheterization\n* Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose'}, 'identificationModule': {'nctId': 'NCT00368706', 'briefTitle': 'A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': '90506/CHoTD01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: solifenacin succinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: tolterodine']}], 'interventions': [{'name': 'solifenacin succinate', 'type': 'DRUG', 'otherNames': ['Vesicare', 'YM905'], 'description': 'Oral', 'armGroupLabels': ['1']}, {'name': 'tolterodine', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '404000', 'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 45.88029, 'lon': 127.13373}}, {'zip': '310000', 'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '200000', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma Inc.'}}}}