Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT00966004
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2009-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Efficacy of YM178 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'}, {'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': 'C520025', 'term': 'mirabegron'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2010-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the mean number of micturitions per 24 hours', 'timeFrame': 'Within a 12-week treatment period'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the mean number of urgency episodes per 24 hours', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change from baseline in the mean number of urinary incontinence episode per 24 hours', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change from baseline in the mean number of urge incontinence episodes per 24 hours', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change from baseline in the mean volume voided per micturition', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': 'Change from baseline in mean number of nocturia episodes', 'timeFrame': 'Within a 12-week treatment period'}, {'measure': "Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire", 'timeFrame': 'Within a 12-week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urge incontinence', 'YM178', 'Overactive Bladder', 'Urgency', 'Urinary incontinence', 'mirabegron', 'Micturition'], 'conditions': ['Urinary Bladder, Overactive']}, '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.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=193', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.', 'detailedDescription': 'This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.\n\nThe drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period\n* Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself\n* Patient with an average frequency of micturition of 8 or more times per 24-hour period\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Patients without experience of urge incontinence before informed consent\n* Patients given a clear diagnosis of stress incontinence\n* Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)\n* Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis\n* Patients with a previous history of recurrent urinary tract infection\n* Patients complicated with or with a history of bladder tumor or prostatic tumor\n* Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease\n* Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period\n* Patients with an indwelling catheter or practicing intermittent self-catheterization\n* Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia\n* Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period\n* Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \\< 50 bpm\n* Patients with polyuria exceeding 3000 mL in mean daily urine volume\n* Patients meeting any of the following in the examinations\n\n * Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee\n * Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)\n * Patients with a blood creatinine level ≥ 2.0 mg/dL'}, 'identificationModule': {'nctId': 'NCT00966004', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': '178-CL-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM178 group', 'description': 'oral', 'interventionNames': ['Drug: YM178']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'oral', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tolterodine group', 'description': 'oral', 'interventionNames': ['Drug: tolterodine']}], 'interventions': [{'name': 'YM178', 'type': 'DRUG', 'otherNames': ['mirabegron'], 'description': 'oral', 'armGroupLabels': ['YM178 group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo group']}, {'name': 'tolterodine', 'type': 'DRUG', 'otherNames': ['Detrol', 'Detrusitol'], 'description': 'oral', 'armGroupLabels': ['tolterodine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kinki', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}