Fesoterodine "add-on" Male Overactive Bladder Study

NCT00546637 | Completed Phase 3 Results

• 1 other identifier: A0221009
• Study Type: interventional
• Target: 947
• Locations: 19 countries
• Sites: 137

Brief Summary

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12

  The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

  Baseline, Week 12

Secondary Outcomes (33)

• Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4

  Baseline, Week 4

• Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

  Baseline, Week 4 and 12

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

  Baseline, Week 4 and 12

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

  Baseline, Week 4 and 12

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

  Baseline, Week 4 and 12

Study Arms (2)

Fesoterodine 4mg or 8mg

EXPERIMENTAL

Drug: Fesoterodine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fesoterodine DRUG

Fesoterodine 4mg or 8mg

Fesoterodine 4mg or 8mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 40 years and above.
• On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
• Persistent symptoms of OAB with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours.

You may not qualify if:

• Contraindication to fesoterodine (antimuscarinics).
• 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 (137)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

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Gilbert, Arizona, 85234, United States

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Gilbert, Arizona, 85295, United States

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Litchfield Park, Arizona, 85340, United States

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Mesa, Arizona, 85210, United States

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Phoenix, Arizona, 85021, United States

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Tucson, Arizona, 85712, 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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San Bernardino, California, 92404, 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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Aurora, Colorado, 80012, United States

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Denver, Colorado, 80211, United States

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Jupiter, Florida, 33458, United States

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Orange City, Florida, 32763, United States

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West Palm Beach, Florida, 33401, United States

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Dunwoody, Georgia, 30338, 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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Des Moines, Iowa, 50309, United States

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Iowa City, Iowa, 52242, United States

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Baltimore, Maryland, 21204, United States

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Owings Mills, Maryland, 21117, United States

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Watertown, Massachusetts, 02472, United States

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Flint, Michigan, 48507, United States

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Saint Clair Shores, Michigan, 48081, United States

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Troy, Michigan, 48084, United States

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Utica, Michigan, 48081, United States

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West Bloomfield, Michigan, 48322, United States

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West Bloomfield, Michigan, 48323, United States

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Minneapolis, Minnesota, 55455, United States

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Omaha, Nebraska, 68114, United States

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Sewell, New Jersey, 08080, United States

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Albany, New York, 12208, 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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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, 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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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27403, United States

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Fargo, North Dakota, 58103, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45242, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43220, United States

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Bethany, Oklahoma, 73008, United States

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Portland, Oregon, 97239, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Camp Hill, Pennsylvania, 17011, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29425, United States

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Greer, South Carolina, 29650, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78759, United States

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Houston, Texas, 77024, United States

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Tacoma, Washington, 98431-1100, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53209, United States

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Antwerp, 2020, Belgium

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Edegem, B-2650, Belgium

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Leuven, B-3000, Belgium

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Salvador, Estado de Bahia, 40420-000, Brazil

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Curitiba, Paraná, 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro, CEP 20551-030, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Campos do Jordão, São Paulo, 12460-000, Brazil

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São Paulo, São Paulo, 04262-000, Brazil

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Victoria, British Columbia, V8T 5G1, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Barrie, Ontario, L4M 7G1, Canada

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North Bay, Ontario, P1B 7K8, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Toronto, Ontario, M6A 3B5, Canada

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Chicoutimi, Quebec, G7H 4A3, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Medellín, Antioquia, 0000, Colombia

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Bogota, Cundinamarca, 0000, Colombia

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Berlin, 12627, Germany

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Frankfurt, 60596, Germany

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Göttingen, 37073, Germany

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Hagenow, 19230, Germany

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Lauenburg, 21481, Germany

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Leipzig, 04109, Germany

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Oberursel, 61440, Germany

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Wiesbaden, 65198, Germany

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Ioannina, Ipiros, 45 110, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 56403, Greece

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New Delhi, New Delhi, 110029, India

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Ludhiana, Punjab, 141008, India

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Lucknow, Uttar Pradesh, 226003, India

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Lucknow, Uttar Pradesh, 226014, India

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Kuching, Sarawak, 93050, Malaysia

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Kuching, Sarawak, 93586, Malaysia

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Roermond, 6043 CV, Netherlands

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Tilburg, 5022 GC, Netherlands

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Zutphen, 7207 BA, Netherlands

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Bodø, 8087, Norway

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Oslo, NO-0257, Norway

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Cebu City, Cebu, 6000, Philippines

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Quezon City, Philippines, 1113, Philippines

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Bacolod City, 6100, Philippines

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Makati City, 1200, Philippines

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Manila, 1000, Philippines

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Manila, 1008, Philippines

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Bialystok, 15-232, Poland

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Gdansk, 80-402, Poland

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Gdansk, 80-462, Poland

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Lodz, 93-338, Poland

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Mysłowice, 41-400, Poland

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Wroclaw, 51-124, Poland

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Singapore, Singapore, 169608, Singapore

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Singapore, Singapore, 308433, Singapore

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Bratislava, Slovakia, 833 05, Slovakia

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Martin, Slovakia, 036 59, Slovakia

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Piešťany, Slovakia, 921 01, Slovakia

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Banská Bystrica, 974 01, Slovakia

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Skalica, 909 82, Slovakia

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Bucheon-si, Gyunggi-do, 420-717, South Korea

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Pusan, 602-739, South Korea

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Seoul, 135-710, South Korea

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Seoul, 135-720, South Korea

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Martorell, Barcelona, 08760, Spain

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Getafe, Madrid, 28905, Spain

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Manacor, Palma de Mallorca, 07500, Spain

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Borås, 503 32, Sweden

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Jönköping, 554 66, Sweden

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Skövde, 541 30, Sweden

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Stockholm, 117 94, Sweden

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Stockholm, 141 86, Sweden

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Ratchathewi, Bangkok, 10400, Thailand

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Amphoe Mueang, Chiang Mai, 50200, Thailand

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Related Links

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

MeSH Terms

Interventions

fesoterodine

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: October 18, 2007
• First Posted: October 19, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 18, 2011
• Results First Posted: November 22, 2010

Record last verified: 2011-02

Locations

PL (6); BE (3); TH (2); CA (9); KR (4); MY (2); CO (2); SE (5); US (62); BR (6); NO (2); SL (5); IN (4); GR (3); NL (3); SG (2); ES (3); DE (8); PH (6)