A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
NCT ID: NCT00350636
Last Updated: 2010-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
789 participants
INTERVENTIONAL
2006-06-30
2007-05-31
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
TRIPLE
Study Groups
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Oxybutynin topical gel
Oxybutynin topical gel
Oxybutynin topical gel
1 application daily to skin for 12 weeks
Placebo topical gel
placebo topical gel
Placebo topical gel
1 application daily to skin for 12 weeks
Interventions
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Oxybutynin topical gel
1 application daily to skin for 12 weeks
Placebo topical gel
1 application daily to skin for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Watson
Principal Investigators
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Kim Caramelli, MS
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Homewood, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Buena Park, California, United States
Laguna Woods, California, United States
Sacramento, California, United States
San Diego, California, United States
Torrance, California, United States
Denver, Colorado, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Leesburg, Florida, United States
Ocala, Florida, United States
Plantation, Florida, United States
Tallahassee, Florida, United States
West Palm Beach, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Belville, Illinois, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Evansville, Indiana, United States
South Bend, Indiana, United States
Shreveport, Louisiana, United States
Watertown, Massachusetts, United States
Saginaw, Michigan, United States
Saint Joseph, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Garden City, New York, United States
New York, New York, United States
Williamsville, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lyndhurst, Ohio, United States
Bethany, Oklahoma, United States
Edmond, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Newton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Countries
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References
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Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.
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.
Related Links
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Other Identifiers
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OG05009
Identifier Type: -
Identifier Source: org_study_id
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