Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00749632
Status:
COMPLETED
Last Update Posted:
2009-10-15
First Post:
2008-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'dispFirstSubmitDate': '2009-10-13', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2008-09-05', 'dispFirstSubmitQcDate': '2009-10-13', 'studyFirstSubmitQcDate': '2008-09-08', 'dispFirstPostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of micturations and incontinence episodes.', 'timeFrame': 'Two weeks pretreatment and three weeks on treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary incontinence, urge', 'urinary urge incontinence', 'urge incontinence', 'over active bladder'], 'conditions': ['Urinary Incontinence, Urge']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females 18 to 75 years of age\n* Has reported symptoms of urge urinary incontinence/overactive bladder\n\nExclusion Criteria:\n\n* Is pregnant or lactating\n* Has had lower urinary tract surgery within 6 months prior to Screening\n* Has a history of urinary retention'}, 'identificationModule': {'nctId': 'NCT00749632', 'acronym': 'FP1097-002', 'briefTitle': 'A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'FemmePharma Global Healthcare, Inc.'}, 'officialTitle': 'An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence', 'orgStudyIdInfo': {'id': 'FP1097-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: oxybutynin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: oxybutynin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: oxybutynin']}], 'interventions': [{'name': 'oxybutynin', 'type': 'DRUG', 'description': 'low dose oxybutynin administered daily', 'armGroupLabels': ['1']}, {'name': 'oxybutynin', 'type': 'DRUG', 'description': 'middle dose oxybutynin administered daily', 'armGroupLabels': ['2']}, {'name': 'oxybutynin', 'type': 'DRUG', 'description': 'high dose oxybutynin administered daily', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SNBL Clinical Pharmacology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Biomedical Research', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'Peter K. Mays, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FemmePharma Global Healthcare, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FemmePharma Global Healthcare, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Peter K. Mays, Ph.D. / V.P. Pharmaceutical Development', 'oldOrganization': 'FemmePharma Global Healthcare, Inc.'}}}}