Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 7:31 PM
Study NCT ID:
NCT01003405
Status:
WITHDRAWN
Last Update Posted:
2010-07-27
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Safety and Efficacy 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-25', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The long-term safety of KUC-7483 for the treatment of overactive bladder.', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'The long-term efficacy of KUC-7483 for the treatment of overactive bladder.', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder', 'Frequency', 'Micturition', 'Urgency', 'Urge urinary incontinence', 'OAB'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have successfully completed the Phase III double-blind study.\n\nExclusion Criteria:\n\n* Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.'}, 'identificationModule': {'nctId': 'NCT01003405', 'briefTitle': 'Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': 'KUC1302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KUC-7483', 'interventionNames': ['Drug: KUC-7483']}], 'interventions': [{'name': 'KUC-7483', 'type': 'DRUG', 'armGroupLabels': ['KUC-7483']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Yasuhiro Omori', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Development Department, Kissei pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}