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Fesoterodine Flexible Dose Study

NCT ID: NCT00536484

Last Updated: 2009-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fesoterodine (Double-Blind)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Placebo (Double-Blind)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Interventions

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Fesoterodine

4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Intervention Type DRUG

Placebo

Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overactive bladder symptoms for greater than or equal to 3 months.
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
* Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria

* Contraindication to fesoterodine (antimuscarinics).
* Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
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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Pfizer Inc

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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Chandler, Arizona, United States

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Peoria, Arizona, United States

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Tucson, Arizona, United States

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Rancho Cordova, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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New Britain, Connecticut, United States

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Aventura, Florida, United States

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Bonita Springs, Florida, United States

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Hollywood, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Stuart, Florida, United States

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Tallahassee, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Jeffersonville, Indiana, United States

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Newburgh, Indiana, United States

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Iowa City, Iowa, 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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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Baltimore, Maryland, United States

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Bel Air, Maryland, United States

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Milford, Massachusetts, United States

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Springfield, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Paw Paw, Michigan, United States

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Royal Oak, Michigan, United States

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Troy, Michigan, United States

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Picayune, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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New Brunswick, New Jersey, 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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Rochester, New York, United States

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Syracuse, New York, United States

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Williamsville, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, 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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Cincinnati, Ohio, United States

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Bethany, Oklahoma, United States

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Norman, Oklahoma, United States

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Portland, Oregon, United States

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Lansdale, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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State College, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Cumberland, Rhode Island, United States

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Warwick, Rhode Island, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

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Johnson City, 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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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Arlington, Virginia, 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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Spokane, Washington, 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=A0221014&StudyName=Fesoterodine%20flexible%20dose%20study

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0221014

Identifier Type: -

Identifier Source: org_study_id

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