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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

963 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fesoterodine

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Fesoterodine 4mg and 8 mg tablets taken daily.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo sham 4mg and 8 mg tables taken daily.

Interventions

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Fesoterodine

Fesoterodine 4mg and 8 mg tablets taken daily.

Intervention Type DRUG

Placebo

Placebo sham 4mg and 8 mg tables taken daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mean urinary frequency of \>=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
* 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

* A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
* Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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United States

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.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221048

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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