Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-22 @ 2:51 PM
Study NCT ID:
NCT00366002
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
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': 'C101207', 'term': 'darifenacin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2006-08-17', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC)."}], 'secondaryOutcomes': [{'measure': "Patient's perception of outcome using the PPBC questionnaire at Week 7."}, {'measure': "Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13."}, {'measure': 'Assessment of efficacy of darifenacin with respect to change from baseline in:'}, {'measure': 'Number of micturitions per day at Weeks 7 and 13'}, {'measure': 'Number of urgency episodes per day at Weeks 7 and 13'}, {'measure': 'Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13'}, {'measure': 'Assessment of safety and tolerability'}]}, 'conditionsModule': {'keywords': ['Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist'], 'conditions': ['Overactive Bladder (OAB)']}, 'referencesModule': {'references': [{'pmid': '20860020', 'type': 'DERIVED', 'citation': 'Zinner N, Kobashi K, Koochaki P, Fix D, Egermark M. Patient satisfaction with the benefits of overactive bladder treatment: exploration of influencing factors and development of a satisfaction assessment instrument. Neurourol Urodyn. 2011 Jan;30(1):62-8. doi: 10.1002/nau.20890. Epub 2010 Sep 21.'}, {'pmid': '18811599', 'type': 'DERIVED', 'citation': 'Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P. Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. Int J Clin Pract. 2008 Nov;62(11):1664-74. doi: 10.1111/j.1742-1241.2008.01893.x. Epub 2008 Sep 22.'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Symptoms of OAB for at least six months prior to randomization\n\n * ≥ 8 micturitions on average/24 hours\n * ≥ 1 urgency episodes on average/24 hours\n * with or without UUIE\n\n * Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.\n * Patients without prior darifenacin treatment\n\nExclusion Criteria:\n\n* • A mean daily urinary volume \\>3000 mL or a mean volume voided/micturition of \\>300 mL as verified in the micturition diary for two consecutive days prior to Baseline\n\n * Males with post-void residual (PVR) urinary volume \\>200 mL at Baseline\n * Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator\n * Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator\n\nOther protocol-defined inclusion / exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00366002', 'briefTitle': "Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy", 'orgStudyIdInfo': {'id': 'CDAR328A2404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Darifenacin', 'interventionNames': ['Drug: Darifenacin']}], 'interventions': [{'name': 'Darifenacin', 'type': 'DRUG', 'otherNames': ['Enablex'], 'description': 'Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': 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