Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00782769
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2008-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety Extension Study of DR-OXY-301
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2011-08-16', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2008-10-29', 'dispFirstSubmitQcDate': '2011-08-16', 'studyFirstSubmitQcDate': '2008-10-29', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported', 'timeFrame': 'Duration of Study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed the 12 weeks of treatment in the DR-OXY-301 study\n* Willing to limit medications for overactive bladder to investigational product only\n* Able to understand and complete all study procedures including the required diary'}, 'identificationModule': {'nctId': 'NCT00782769', 'briefTitle': 'A Safety Extension Study of DR-OXY-301', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder', 'orgStudyIdInfo': {'id': 'DR-OXY-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxybutinyn Vaginal Ring 4mg', 'description': 'inserted daily and replaced every 4 weeks', 'interventionNames': ['Drug: Oxybutinyn Vaginal Ring 4mg']}, {'type': 'EXPERIMENTAL', 'label': 'Oxybutinyn Vaginal Ring 6mg', 'description': 'inserted daily and replaced every 4 weeks', 'interventionNames': ['Drug: Oxybutinyn Vaginal Ring 6mg']}], 'interventions': [{'name': 'Oxybutinyn Vaginal Ring 4mg', 'type': 'DRUG', 'otherNames': ['DR-3001'], 'armGroupLabels': ['Oxybutinyn Vaginal Ring 4mg']}, {'name': 'Oxybutinyn Vaginal Ring 6mg', 'type': 'DRUG', 'otherNames': ['DR-3001'], 'armGroupLabels': ['Oxybutinyn Vaginal Ring 6mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 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