A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)
NCT ID: NCT00454896
Last Updated: 2014-09-18
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
PHASE3
739 participants
INTERVENTIONAL
2004-05-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
VESIcare®
Oral
2
placebo
Oral
Interventions
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VESIcare®
Oral
placebo
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
* Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.
Exclusion Criteria
* Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for \<3 months
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Atherton, California, United States
Carmichael, California, United States
Escondido, California, United States
Fresno, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Mission Viejo, California, United States
Salinas, California, United States
Valley Village, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
New London, Connecticut, United States
Norwalk, Connecticut, United States
Trumbull, Connecticut, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Boyton Beach, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Tallahassee, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Marietta, Georgia, United States
Boise, Idaho, United States
Centralia, Illinois, United States
Slidell, Louisiana, United States
Bloomfield Hills, Michigan, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Lawrenceville, New Jersey, United States
South Bound Brook, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
East Syracuse, New York, United States
Hewlett, New York, United States
Lewiston, New York, United States
New York, New York, United States
Concord, North Carolina, United States
Hickory, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Eugene, Oregon, United States
Endwell, Pennsylvania, United States
Media, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Athens, Texas, United States
Ogden, Utah, United States
West Point, Utah, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Vancouver, Washington, United States
Morgantown, West Virginia, United States
Countries
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References
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Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.
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.
Serels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582.
Other Identifiers
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905-UC-005
Identifier Type: -
Identifier Source: org_study_id
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