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A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

NCT ID: NCT00928070

Last Updated: 2013-01-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

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Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

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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

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Fesoterodine 4 mg and 8 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo sham 4 mg and 8 mg

Interventions

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Fesoterodine

Fesoterodine 4 mg and 8 mg

Intervention Type DRUG

Placebo

Placebo sham 4 mg and 8 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female subjects 65 years of age or older
* OAB symptoms for at least 3 months
* score 3 or greater on Vulnerable Elderly Survey (VES-13)
* adequate mobility for independent toileting
* mean number of at least 2 UUI episodes per 24 hours
* mean urinary frequency of 8 or more micturitions per 24 hours
* able to independently complete the bladder diaries

Exclusion Criteria

* PVR urinary volume greater than 200 ml
* MMSE score less than 20
* greater than 15 UUI episodes per 24 hours
* creatinine clearance less than 30 ml/min
* an average resting heart rate of greater than or equal to 90 beats per minute
Minimum Eligible Age

65 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

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Montgomery, Alabama, United States

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Green Valley, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tuscon, Arizona, United States

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Fairfield, California, United States

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Glendora, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Murrieta, California, United States

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Norwalk, California, United States

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Paramount, California, United States

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Rancho Santa Margarita, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Temecula, California, United States

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Vacaville, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, 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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Englewood, Colorado, United States

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Longmont, Colorado, United States

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Parker, Colorado, United States

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Groton, Connecticut, United States

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Milford, Connecticut, United States

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New London, Connecticut, United States

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Bonita Springs, Florida, United States

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Boynton Beach, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Lake Worth, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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New Port Richey, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Plant City, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Trinity, Florida, United States

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Wellington, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Newburgh, Indiana, United States

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Arkansas City, Kansas, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Towson, Maryland, United States

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Springfield, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Kalamazoo, Michigan, United States

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Edina, Minnesota, United States

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Picayune, Mississippi, United States

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Southaven, 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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Las Vegas, Nevada, United States

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Moorestown, New Jersey, United States

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Sewell, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Staten Island, 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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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Willoughby Hills, Ohio, United States

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Bethany, Oklahoma, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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East Providence, Rhode Island, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Leander, Texas, United States

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Longview, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Richmond, Virginia, United States

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Burien, 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)

Dubeau CE, Kraus SR, Griebling TL, Newman DK, Wyman JF, Johnson TM 2nd, Ouslander JG, Sun F, Gong J, Bavendam T. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial. J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21.

Reference Type DERIVED
PMID: 23973522 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221049&StudyName=A%20Study%20Of%20Efficacy%20And%20Safety%20Of%20Fesoterodine%20In%20Vulnerable%20Elderly%20Subjects%20With%20Overactive%20Bladder

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

Other Identifiers

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A0221049

Identifier Type: -

Identifier Source: org_study_id

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