Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00212732
Status:
COMPLETED
Last Update Posted:
2012-10-11
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C120953', 'term': 'imidafenacin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of urinary incontinence episodes per week'}], 'secondaryOutcomes': [{'measure': 'Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL'}]}, 'conditionsModule': {'keywords': ['ONO-8025, KRP-197, overactive bladder, antimuscarinic'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '37160401', 'type': 'DERIVED', 'citation': 'Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are 20 years old or over with overactive bladder\n2. Total number of urinary incontinence episodes per week is 5 or over\n3. Mean number of micturition per day is 8 or over\n4. Mean number of urinary urgency episodes per day is 1 or over\n5. Other inclusion criteria as specified in the study protocol\n\nExclusion Criteria:\n\n1. Patients with genuine stress incontinence\n2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection\n3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study\n4. Patients suffering from complications for which anticholinergics are contraindicated\n5. Other exlcusion criteria as specified in the study protocol'}, 'identificationModule': {'nctId': 'NCT00212732', 'briefTitle': 'Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan', 'orgStudyIdInfo': {'id': 'ONO-8025-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONO-8025 (KRP-197)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Project Leader, Development Planning', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}