A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT ID: NCT00911937
Last Updated: 2018-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
963 participants
INTERVENTIONAL
2009-08-31
2011-09-30
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
TRIPLE
Study Groups
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Fesoterodine
Fesoterodine
Fesoterodine 4mg and 8 mg tablets taken daily.
Placebo
Placebo
Placebo sham 4mg and 8 mg tables taken daily.
Interventions
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Fesoterodine
Fesoterodine 4mg and 8 mg tablets taken daily.
Placebo
Placebo sham 4mg and 8 mg tables taken daily.
Eligibility Criteria
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Inclusion Criteria
* Mean number of micturition related urgency episodes \>=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating \>=3)
* Mean number of micturition related nocturnal urgency episodes \>=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of \>3 recorded in the bed time section of the bladder diary)
Exclusion Criteria
* Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Mobile, Alabama, United States
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Goodyear, Arizona, United States
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Litchfield Park, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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La Mesa, California, United States
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Newport Beach, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Tarzana, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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New Britain, Connecticut, United States
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Norwalk, Connecticut, United States
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Dover, Delaware, United States
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Bonita Springs, Florida, United States
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Brooksville, Florida, United States
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DeFuniak Springs, Florida, United States
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Destin, Florida, United States
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Leesburg, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Fort Wayne, Indiana, United States
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Jeffersonville, Indiana, United States
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Iowa City, Iowa, United States
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West Des Moines, Iowa, United States
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Newton, Kansas, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Pratt, Kansas, United States
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Madisonville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Fall River, Massachusetts, United States
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Hyannis, Massachusetts, United States
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Milford, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Watertown, Massachusetts, United States
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Troy, Michigan, United States
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Chaska, Minnesota, United States
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Olive Branch, Mississippi, 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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Hamilton, New Jersey, United States
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Brooklyn, New York, United States
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Garden City, New York, United States
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Kingston, New York, United States
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Manlius, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Burlington, North Carolina, United States
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Cary, 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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Huntersville, North Carolina, United States
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Salisbury, North Carolina, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Westerville, Ohio, United States
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Portland, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Bridgeville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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East Greenwich, Rhode Island, United States
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Pawtucket, Rhode Island, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Bristol, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Milan, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Mountlake Terrace, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Menomonee Falls, Wisconsin, United States
Countries
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References
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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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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0221048
Identifier Type: -
Identifier Source: org_study_id
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