Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00196404
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the total weekly number of incontinence episodes', 'timeFrame': 'Baseline to Treatment Week 12/Premature Discontinuation'}], 'secondaryOutcomes': [{'measure': 'Average daily urinary frequency', 'timeFrame': 'Baseline to Treatment Week 12/Premature Discontinuation'}, {'measure': 'Proportion of patients with no incontinence episodes', 'timeFrame': 'Baseline to Treatment Week 12/Premature Discontinuation'}, {'measure': 'Average void volume', 'timeFrame': 'Baseline to Treatment Week 12/Premature Discontinuation'}, {'measure': 'Average severity of urgency', 'timeFrame': 'Baseline to Treatment Week 12/Premature Discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'urge incontinence', 'urinary incontinence'], 'conditions': ['Urinary Incontinence']}, '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': 'http://www.nlm.nih.gov/medlineplus/urinaryincontinence.html', 'label': 'MedLine Plus - Urinary Incontinence'}]}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency', 'detailedDescription': 'This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of overactive bladder and incontinence for at least 6 months\n* Using birth control or menopausal\n* Willing to discontinue current medication for overactive bladder\n\nExclusion Criteria:\n\n* Pregnant or given birth in the last 6 months\n* Three or more urinary tract infections a year\n* Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis\n* History of bladder cancer, ulcerative colitis or severe constipation\n* Any contraindication to vaginal delivery systems'}, 'identificationModule': {'nctId': 'NCT00196404', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder', 'orgStudyIdInfo': {'id': 'BR-OXY-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DR-3001a']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: DR-3001b']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'DR-3001a', 'type': 'DRUG', 'description': '4mg daily vaginally', 'armGroupLabels': ['1']}, {'name': 'DR-3001b', 'type': 'DRUG', 'description': '6 mg vaginally daily', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered vaginally to match experimental arms', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 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