Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT00742833
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2008-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of KUC-7483 in Patients With 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': 'C576375', 'term': 'ritobegron ethyl'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-02', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean number of micturitions per 24 hours', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean number of urgency episodes per 24 hours', 'timeFrame': '12 weeks'}, {'measure': 'Change from baseline in mean number of incontinence episodes per 24 hours', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder', 'Frequency', 'Micturition', 'Urgency', 'Urge urinary incontinence', 'β3-agonist'], 'conditions': ['Overactive Bladder (OAB)']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a symptom of overactive bladder for more than 6 months.\n* Patients who meet the following condition during the 3-day bladder diary period.\n\n * the mean number of micturitions per 24 hours is ≥8 times\n * the mean number of urgency episodes per 24 hours is ≥1 time\n\nExclusion Criteria:\n\n* Patients who are diagnosed as stress urinary incontinence are predominant.\n* Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.'}, 'identificationModule': {'nctId': 'NCT00742833', 'briefTitle': 'A Phase II Study of KUC-7483 in Patients With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': 'KUC1203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: KUC-7483']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KUC-7483', 'type': 'DRUG', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kansai Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Yasuhiro Omori', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}