- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00366002
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
January 14, 2008 updated by: Novartis
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35242
- Investigative Site
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Arizona
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Chandler, Arizona, United States, 85224
- Investigative Site
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Mesa, Arizona, United States, 85206
- Investigative Site
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Sierra Vista, Arizona, United States, 85635
- Investigative Site
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Tempe, Arizona, United States, 85282
- Investigative Site
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California
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Atherton, California, United States, 94027
- Investigative Site
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Los Angeles, California, United States, 90048
- Investigative Site
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Newport Beach, California, United States, 92660
- Investigative Site
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San Diego, California, United States, 92108
- Investigative Site
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Temecula, California, United States, 92591
- Investigative Site
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Torrance, California, United States, 90505
- Investigative Site
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Upland, California, United States, 91786
- Investigative Site
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Colorado
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Aurora, Colorado, United States, 80012
- Investigative Site
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Littleton, Colorado, United States, 80122
- Investigative Site
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Wheat Ridge, Colorado, United States, 80033
- Investigative Site
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Florida
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Hollywood, Florida, United States, 33021
- Investigative Site
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New Smyrna Beach, Florida, United States, 32168
- Investigative Site
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Ocala, Florida, United States, 34474
- Investigative Site
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Orlando, Florida, United States, 32803
- Investigative Site
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Sarasota, Florida, United States, 34237
- Investigative Site
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Tampa, Florida, United States, 33607
- Investigative Site
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West Palm Beach, Florida, United States, 33409
- Investigative Site
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Weston, Florida, United States, 33331
- Investigative Site
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Georgia
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Alpharetta, Georgia, United States, 30005
- Investigative Site
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Atlanta, Georgia, United States, 30342
- Investigative Site
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Marietta, Georgia, United States, 30060
- Investigative Site
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Roswell, Georgia, United States, 30076
- Investigative Site
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Snellville, Georgia, United States, 30078
- Investigative Site
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Illinois
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Melrose Park, Illinois, United States, 60160
- Investigative Site
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O'Fallon, Illinois, United States, 62269
- Investigative Site
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Peoria, Illinois, United States, 61615
- Investigative Site
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Indiana
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Evansville, Indiana, United States, 47714
- Investigative Site
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Greenwood, Indiana, United States, 46143
- Investigative Site
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Kansas
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Topeka, Kansas, United States, 66606
- Investigative Site
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Massachusetts
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Milford, Massachusetts, United States, 01757
- Investigative Site
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Watertown, Massachusetts, United States, 02472
- Investigative Site
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Michigan
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Flint, Michigan, United States, 48507
- Investigative Site
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Saint Joseph, Michigan, United States, 49085
- Investigative Site
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Missouri
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Chesterfield, Missouri, United States, 63017
- Investigative Site
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Kansas City, Missouri, United States, 64114
- Investigative Site
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St. Louis, Missouri, United States, 63136
- Investigative Site
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Investigative Site
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Omaha, Nebraska, United States, 68114
- Investigative Site
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Investigative Site
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West Orange, New Jersey, United States, 07052
- Investigative Site
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New York
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Albany, New York, United States, 12206
- Investigative Site
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Garden City, New York, United States, 11530
- Investigative Site
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Latham, New York, United States, 12110
- Investigative Site
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Mineola, New York, United States, 11501
- Investigative Site
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New Hartford, New York, United States, 13413
- Investigative Site
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Poughkeepsie, New York, United States, 12601
- Investigative Site
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Troy, New York, United States, 12180
- Investigative Site
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Williamsville, New York, United States, 14221
- Investigative Site
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North Carolina
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Burlington, North Carolina, United States, 27215
- Investigative Site
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Charlotte, North Carolina, United States, 28209
- Investigative Site
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Concord, North Carolina, United States, 28205
- Investigative Site
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Hickory, North Carolina, United States, 28601
- Investigative Site
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High Point, North Carolina, United States, 27262
- Investigative Site
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Salisbury, North Carolina, United States, 28144
- Investigative Site
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Winston Salem, North Carolina, United States, 27103
- Investigative Site
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Ohio
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Cincinnati, Ohio, United States, 45212
- Investigative Site
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Oklahoma
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Bethany, Oklahoma, United States, 73008
- Investigative Site
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Edmond, Oklahoma, United States, 73034
- Investigative Site
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Oregon
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Portland, Oregon, United States, 97205
- Investigative Site
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Springfield, Oregon, United States, 97477
- Investigative Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Investigative Site
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Texas
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Amarillo, Texas, United States, 79106
- Investigative Site
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Corsicana, Texas, United States, 75110
- Investigative Site
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Dallas, Texas, United States, 75231
- Investigative Site
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Fort Worth, Texas, United States, 76104
- Investigative Site
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Houston, Texas, United States, 77005
- Investigative Site
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Lake Jackson, Texas, United States, 77566
- Investigative Site
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Utah
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Bountiful, Utah, United States, 84010
- Investigative Site
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Salt Lake City, Utah, United States, 84124
- Investigative Site
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Sandy, Utah, United States, 84070
- Investigative Site
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Virginia
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Richmond, Virginia, United States, 23294
- Investigative Site
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Washington
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Everett, Washington, United States, 98208
- Investigative Site
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Lakewood, Washington, United States, 98499
- Investigative Site
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Mountlake Terrace, Washington, United States, 98233
- Investigative Site
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Seattle, Washington, United States, 98101
- Investigative Site
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Vancouver, Washington, United States, 98664
- Investigative Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Symptoms of OAB for at least six months prior to randomization
- ≥ 8 micturitions on average/24 hours
- ≥ 1 urgency episodes on average/24 hours
with or without UUIE
- 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.
- Patients without prior darifenacin treatment
Exclusion Criteria:
• 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
- Males with post-void residual (PVR) urinary volume >200 mL at Baseline
- Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
- Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
Other protocol-defined inclusion / exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Darifenacin
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Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
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Secondary Outcome Measures
Outcome Measure |
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Patient's perception of outcome using the PPBC questionnaire at Week 7.
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Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
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Assessment of efficacy of darifenacin with respect to change from baseline in:
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Number of micturitions per day at Weeks 7 and 13
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Number of urgency episodes per day at Weeks 7 and 13
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Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
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Assessment of safety and tolerability
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Novartis Pharmaceutical Corporation, NPC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
August 17, 2006
First Submitted That Met QC Criteria
August 17, 2006
First Posted (Estimate)
August 18, 2006
Study Record Updates
Last Update Posted (Estimate)
January 15, 2008
Last Update Submitted That Met QC Criteria
January 14, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Darifenacin
Other Study ID Numbers
- CDAR328A2404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overactive Bladder (OAB)
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Stimvia s.r.o.CompletedOveractive Bladder (OAB) | Failed Any OAB PharmacotherapyCzechia
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Astellas Pharma Singapore Pte. Ltd.CompletedOveractive Bladder (OAB)Korea, Republic of, Australia
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Jeil Pharmaceutical Co., Ltd.CompletedOveractive Bladder(OAB)Korea, Republic of
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Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
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Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
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Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
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Astellas Pharma Singapore Pte. Ltd.CompletedOveractive Bladder (OAB)Korea, Republic of, Australia
-
National and Kapodistrian University of AthensCompletedOveractive Bladder (OAB)Greece
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Astellas Pharma Singapore Pte. Ltd.CompletedOveractive Bladder (OAB)Korea, Republic of, Taiwan
Clinical Trials on Darifenacin
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NovartisProcter and GambleCompleted
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BayerCompleted
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BayerTerminatedMultiple Sclerosis | Overactive DetrusorGermany
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Cognitive Research CorporationNovartis PharmaceuticalsWithdrawn
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BayerCompletedOveractive BladderSouth Africa
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McGill UniversityUniversité de MontréalNot yet recruitingAmyotrophic Lateral SclerosisCanada
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US Department of Veterans AffairsCompletedOveractive Bladder | Parkinson's DiseaseUnited States
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Toronto Rehabilitation InstituteOntario Neurotrauma FoundationCompletedSpinal Cord Injury | Neurogenic Detrusor OveractivityCanada
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NovartisCompletedOveractive Bladder SyndromeUnited States
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University of Missouri-ColumbiaTerminatedOveractive Bladder | Renal Colic | Pain, PostoperativeUnited States