Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
NCT ID: NCT00366002
Last Updated: 2008-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2006-06-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Darifenacin
Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Interventions
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Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceutical Corporation
Role: STUDY_CHAIR
NPC
Locations
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
Chandler, Arizona, United States
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Mesa, Arizona, United States
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Sierra Vista, Arizona, United States
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Tempe, Arizona, United States
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Atherton, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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San Diego, California, United States
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Temecula, California, United States
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Torrance, California, United States
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Upland, California, United States
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Aurora, Colorado, United States
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Littleton, Colorado, United States
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Wheat Ridge, Colorado, United States
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Hollywood, Florida, United States
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New Smyrna Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Roswell, Georgia, United States
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Snellville, Georgia, United States
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Melrose Park, Illinois, United States
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O'Fallon, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Greenwood, Indiana, United States
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Topeka, Kansas, United States
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Milford, Massachusetts, United States
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Watertown, Massachusetts, United States
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Flint, Michigan, United States
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Saint Joseph, Michigan, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Lawrenceville, New Jersey, United States
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West Orange, New Jersey, United States
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Albany, New York, United States
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Garden City, New York, United States
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Latham, New York, United States
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Mineola, New York, United States
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New Hartford, New York, United States
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Poughkeepsie, New York, United States
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Troy, New York, United States
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Williamsville, New York, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Bethany, Oklahoma, United States
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Edmond, Oklahoma, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Amarillo, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Bountiful, Utah, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Lakewood, Washington, United States
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Mountlake Terrace, Washington, United States
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Seattle, Washington, United States
Investigative Site
Vancouver, Washington, United States
Investigative Site
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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CDAR328A2404
Identifier Type: -
Identifier Source: org_study_id
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