Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
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
1 other identifier
interventional
500
1 country
82
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2006
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 17, 2006
CompletedFirst Posted
Study publicly available on registry
August 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 15, 2008
January 1, 2008
August 17, 2006
January 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
Secondary Outcomes (7)
Patient's perception of outcome using the PPBC questionnaire at Week 7.
Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
Assessment of efficacy of darifenacin with respect to change from baseline in:
Number of micturitions per day at Weeks 7 and 13
Number of urgency episodes per day at Weeks 7 and 13
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALDarifenacin
Interventions
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Procter and Gamblecollaborator
Study Sites (82)
Investigative Site
Birmingham, Alabama, 35242, United States
Investigative Site
Chandler, Arizona, 85224, United States
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Mesa, Arizona, 85206, United States
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Sierra Vista, Arizona, 85635, United States
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Tempe, Arizona, 85282, United States
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Atherton, California, 94027, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92660, United States
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San Diego, California, 92108, United States
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Temecula, California, 92591, United States
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Torrance, California, 90505, United States
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Upland, California, 91786, United States
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Aurora, Colorado, 80012, United States
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Littleton, Colorado, 80122, United States
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Wheat Ridge, Colorado, 80033, United States
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Hollywood, Florida, 33021, United States
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New Smyrna Beach, Florida, 32168, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32803, United States
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Sarasota, Florida, 34237, United States
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Tampa, Florida, 33607, United States
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West Palm Beach, Florida, 33409, United States
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Weston, Florida, 33331, United States
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Alpharetta, Georgia, 30005, United States
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Atlanta, Georgia, 30342, United States
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Marietta, Georgia, 30060, United States
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Roswell, Georgia, 30076, United States
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Snellville, Georgia, 30078, United States
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Melrose Park, Illinois, 60160, United States
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O'Fallon, Illinois, 62269, United States
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Peoria, Illinois, 61615, United States
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Evansville, Indiana, 47714, United States
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Greenwood, Indiana, 46143, United States
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Topeka, Kansas, 66606, United States
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Milford, Massachusetts, 01757, United States
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Watertown, Massachusetts, 02472, United States
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Flint, Michigan, 48507, United States
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Saint Joseph, Michigan, 49085, United States
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Chesterfield, Missouri, 63017, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63136, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68114, United States
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Lawrenceville, New Jersey, 08648, United States
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West Orange, New Jersey, 07052, United States
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Albany, New York, 12206, United States
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Garden City, New York, 11530, United States
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Latham, New York, 12110, United States
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Mineola, New York, 11501, United States
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New Hartford, New York, 13413, United States
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Poughkeepsie, New York, 12601, United States
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Troy, New York, 12180, United States
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Williamsville, New York, 14221, United States
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Burlington, North Carolina, 27215, United States
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Charlotte, North Carolina, 28209, United States
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Concord, North Carolina, 28205, United States
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Hickory, North Carolina, 28601, United States
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High Point, North Carolina, 27262, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45212, United States
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Bethany, Oklahoma, 73008, United States
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Edmond, Oklahoma, 73034, United States
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Portland, Oregon, 97205, United States
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Springfield, Oregon, 97477, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Amarillo, Texas, 79106, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75231, United States
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Fort Worth, Texas, 76104, United States
Investigative Site
Houston, Texas, 77005, United States
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Lake Jackson, Texas, 77566, United States
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Bountiful, Utah, 84010, United States
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Salt Lake City, Utah, 84124, United States
Investigative Site
Sandy City, Utah, 84070, United States
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Richmond, Virginia, 23294, United States
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Everett, Washington, 98208, United States
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Lakewood, Washington, 98499, United States
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Mountlake Terrace, Washington, 98233, United States
Investigative Site
Seattle, Washington, 98101, United States
Investigative Site
Vancouver, Washington, 98664, United States
Investigative Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
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: 20860020DERIVEDZinner 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.
PMID: 18811599DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceutical Corporation
NPC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2006
First Posted
August 18, 2006
Study Start
June 1, 2006
Study Completion
September 1, 2007
Last Updated
January 15, 2008
Record last verified: 2008-01