A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

NCT00911937 | Completed Phase 4 Results

• 1 other identifier: A0221048
• Study Type: interventional
• Target: 963
• Locations: 1 country
• Sites: 112

Brief Summary

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

Conditions

Overactive Bladder

Keywords

incontinence OAB urgency nocturia

Outcome Measures

Primary Outcomes (2)

• Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours

  Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

  Baseline

• Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12

  Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

  Baseline and Week 12

Secondary Outcomes (26)

• Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4

  Baseline and Week 4

• Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12

  Baseline, Week 4 and 12

• Number of Nocturnal Micturitions Per 24 Hours

  Baseline

• Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12

  Baseline, Week 4 and 12

• Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12

  Baseline, Week 4 and 12

Study Arms (2)

Fesoterodine

EXPERIMENTAL

Drug: Fesoterodine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fesoterodine DRUG

Fesoterodine 4mg and 8 mg tablets taken daily.

Fesoterodine

Placebo DRUG

Placebo sham 4mg and 8 mg tables taken daily.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (112)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Goodyear, Arizona, 85395, United States

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Litchfield Park, Arizona, 85340, United States

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85741, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93720, United States

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La Mesa, California, 91942, United States

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Newport Beach, California, 92660, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92103-6204, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Tarzana, California, 91356, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Farmington, Connecticut, 06032, United States

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New Britain, Connecticut, 06052, United States

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Norwalk, Connecticut, 06850, United States

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Dover, Delaware, 19904, United States

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Bonita Springs, Florida, 34134, United States

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Brooksville, Florida, 34601, United States

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DeFuniak Springs, Florida, 32435, United States

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Destin, Florida, 32541, United States

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Leesburg, Florida, 34748, United States

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Naples, Florida, 34102, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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Pembroke Pines, Florida, 33024, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33709, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30329-5102, United States

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Coeur d'Alene, Idaho, 83814, United States

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Chicago, Illinois, 60634, United States

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Chicago, Illinois, 60654, United States

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Fort Wayne, Indiana, 46825, United States

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Jeffersonville, Indiana, 47130, United States

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Iowa City, Iowa, 52242, United States

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West Des Moines, Iowa, 50266, United States

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Newton, Kansas, 67114, United States

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Overland Park, Kansas, 66202, United States

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Overland Park, Kansas, 66210, United States

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Overland Park, Kansas, 66211, United States

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Pratt, Kansas, 67124, United States

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Madisonville, Kentucky, 42431, United States

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Mount Sterling, Kentucky, 40353, United States

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Shreveport, Louisiana, 71106, United States

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Annapolis, Maryland, 21401, United States

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Fall River, Massachusetts, 02720, United States

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Hyannis, Massachusetts, 02601, United States

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Milford, Massachusetts, 01757, United States

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New Bedford, Massachusetts, 02740, United States

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Watertown, Massachusetts, 02472, United States

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Troy, Michigan, 48098, United States

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Chaska, Minnesota, 55318, United States

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Olive Branch, Mississippi, 38654, United States

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St Louis, Missouri, 63110, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68114, United States

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Hamilton, New Jersey, 08690, United States

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Brooklyn, New York, 11215, 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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Burlington, North Carolina, 27215, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28207, United States

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Concord, North Carolina, 28025, United States

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Huntersville, North Carolina, 28078, United States

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Salisbury, North Carolina, 28144, United States

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Fargo, North Dakota, 58103, United States

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Akron, Ohio, 44311, United States

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Cincinnati, Ohio, 45249, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43221, United States

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Dayton, Ohio, 45439, United States

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Westerville, Ohio, 43081, United States

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Portland, Oregon, 97225, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Bridgeville, Pennsylvania, 15017, United States

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Lansdale, Pennsylvania, 19446, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Sellersville, Pennsylvania, 18960, United States

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East Greenwich, Rhode Island, 02818, United States

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Pawtucket, Rhode Island, 02860, United States

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Warwick, Rhode Island, 02886, United States

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Anderson, South Carolina, 29621, 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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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37920, United States

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Milan, Tennessee, 38358, 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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Dallas, Texas, 75231, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77079, United States

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Plano, Texas, 75024, 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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Seattle, Washington, 98104, United States

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Spokane, Washington, 99207, United States

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Menomonee Falls, Wisconsin, 53051, 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.gov_Inquiries@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 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 4, 2018
• Results First Posted: August 14, 2012

Record last verified: 2018-11

Locations

US (112)