Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-04 @ 8:24 PM
Study NCT ID:
NCT01901120
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Specified Drug Use-results Survey of Betanis Tablets
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': 'C520025', 'term': 'mirabegron'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1263}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-30', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events', 'timeFrame': 'Up to 36 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Overactive Bladder Symptom Score (OABSS)', 'timeFrame': 'At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Betanis®', 'mirabegron', 'Overactive Bladder'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.'}, 'identificationModule': {'nctId': 'NCT01901120', 'briefTitle': 'Long-Term Specified Drug Use-results Survey of Betanis Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Long-Term Specified Drug Use-results Survey of Betanis Tablets', 'orgStudyIdInfo': {'id': 'BE0002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Betanis', 'description': 'the usual adult dosage of mirabegron once daily after a meal', 'interventionNames': ['Drug: Betanis']}], 'interventions': [{'name': 'Betanis', 'type': 'DRUG', 'otherNames': ['YM178', 'mirabegron'], 'description': 'oral', 'armGroupLabels': ['Betanis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'state': 'Chubu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Chugoku', 'state': 'Chugoku', 'country': 'Japan'}, {'city': 'Hokkaido', 'state': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'state': 'Kansai', 'country': 'Japan'}, {'city': 'Kanto', 'state': 'Kanto', 'country': 'Japan'}, {'city': 'Kyushu', 'state': 'Kyushu', 'country': 'Japan'}, {'city': 'Shikoku', 'state': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'state': 'Tohoku', 'country': 'Japan', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}