Fesoterodine Flexible Dose Study

NCT00536484 | Completed Phase 3 Results

• 1 other identifier: A0221014
• Study Type: interventional
• Target: 896
• Locations: 1 country
• Sites: 95

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.

  The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline

  Baseline and Week 12

Secondary Outcomes (12)

• Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline

  Baseline, Week 2 and Week 6

• Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline

  Baseline, Week 2, Week 6 and Week 12

• Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline

  Baseline, Week 2, Week 6 and Week 12

• Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline

  Baseline, Week 2, Week 6 and Week 12

• Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline

  Baseline, Week 2, Week 6 and Week 12

Study Arms (2)

Fesoterodine (Double-Blind)

EXPERIMENTAL

Drug: Fesoterodine

Placebo (Double-Blind)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fesoterodine 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.

Fesoterodine (Double-Blind)

Placebo 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.

Placebo (Double-Blind)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (95)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85225, United States

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Peoria, Arizona, 85381, United States

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Tucson, Arizona, 85741, United States

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Rancho Cordova, California, 95670, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92103, United States

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Denver, Colorado, 80210, United States

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Denver, Colorado, 80211, United States

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Denver, Colorado, 80218, United States

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Englewood, Colorado, 80112, United States

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New Britain, Connecticut, 06052, United States

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Aventura, Florida, 33180, United States

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Bonita Springs, Florida, 34134, United States

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Hollywood, Florida, 33021, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33176, United States

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Naples, Florida, 34102, United States

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Pembroke Pines, Florida, 33024, United States

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St. Petersburg, Florida, 33709, United States

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Stuart, Florida, 34996, United States

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Tallahassee, Florida, 32308, United States

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Chicago, Illinois, 60610, United States

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Evansville, Indiana, 47713, United States

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Jeffersonville, Indiana, 47130, United States

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Newburgh, Indiana, 47630, United States

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Iowa City, Iowa, 52242, United States

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Overland Park, Kansas, 66210, United States

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Overland Park, Kansas, 66215, United States

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Pratt, Kansas, 67124, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40207, United States

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Louisville, Kentucky, 40291, United States

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Madisonville, Kentucky, 42431, United States

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Baltimore, Maryland, 21204, United States

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Bel Air, Maryland, 21014, United States

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Milford, Massachusetts, 01757, United States

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Springfield, Massachusetts, 01103, United States

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West Yarmouth, Massachusetts, 02673, United States

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Ann Arbor, Michigan, 48103, United States

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Paw Paw, Michigan, 49079, United States

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Royal Oak, Michigan, 48073, United States

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Troy, Michigan, 48098, United States

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Picayune, Mississippi, 39466, United States

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St Louis, Missouri, 63117, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89104, United States

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Las Vegas, Nevada, 89130, United States

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New Brunswick, New Jersey, 08901, United States

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Garden City, New York, 11530, United States

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Kingston, New York, 12401, United States

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Manlius, New York, 13104, United States

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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, United States

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Rochester, New York, 14609, United States

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Syracuse, New York, 13210, United States

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Williamsville, New York, 14221, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28207, United States

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Raleigh, North Carolina, 27609, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45249, United States

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Bethany, Oklahoma, 73008, United States

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Norman, Oklahoma, 73071, United States

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Portland, Oregon, 97239, United States

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Lansdale, Pennsylvania, 19446, United States

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Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19115, United States

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Sellersville, Pennsylvania, 18960, United States

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State College, Pennsylvania, 16801, United States

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Cranston, Rhode Island, 02920, United States

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Cumberland, Rhode Island, 02864, United States

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Warwick, Rhode Island, 02886, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Bristol, Tennessee, 37620, United States

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Johnson City, Tennessee, 36701, United States

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Johnson City, Tennessee, 37601, United States

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Nashville, Tennessee, 37203, United States

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New Tazewell, Tennessee, 37825, United States

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Bryan, Texas, 77802, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77079, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78229, United States

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Arlington, Virginia, 22205, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23294, United States

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Mountlake Terrace, Washington, 98043, United States

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Spokane, Washington, 99207, United States

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Related Publications (1)

• 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.

  PMID: 37160401 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 27, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 15, 2009
• Results First Posted: September 11, 2009

Record last verified: 2009-09

Locations

US (95)