Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

NCT00444925 | Completed Phase 3 Results

• 1 other identifier: A0221008
• Study Type: interventional
• Target: 1,712
• Locations: 28 countries
• Sites: 175

Brief Summary

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).

  UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.

  Baseline, Week 12

Secondary Outcomes (17)

• Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.

  Baseline, Week 1, Week 4

• Percent Change From Baseline of UUI Episodes Per 24 Hours.

  Baseline, Week 1, Week 4, Week 12

• Change From Baseline in Mean Voided Volume Per Micturition.

  Baseline, Week 1, Week 4, Week 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours.

  Baseline, Week 1, Week 4, Week 12

• Percent Change From Baseline of Micturitions Per 24 Hours.

  Baseline, Week 1, Week 4, Week 12

Study Arms (3)

Fesoterodine

EXPERIMENTAL

Tablets

Drug: fesoterodine fumarate

Placebo

PLACEBO COMPARATOR

Tablets and capsules

Drug: placebo

Tolterodine

ACTIVE COMPARATOR

Capsules

Drug: tolterodine tartrate

Interventions

fesoterodine fumarate DRUG

4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

Fesoterodine

placebo DRUG

once daily (OD)for 12 weeks

Placebo

tolterodine tartrate DRUG

4 mg once daily (OD) for 12 weeks

Tolterodine

Eligibility Criteria

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

You may qualify if:

• Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day

You may not qualify if:

• Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (178)

Pfizer Investigational Site

Homewood, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Carmichael, California, 95608, United States

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Orangevale, California, 95662, United States

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San Diego, California, 92103-6204, United States

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Aurora, Colorado, 80012, United States

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Waterbury, Connecticut, 06708, United States

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Miami, Florida, 33186, United States

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Wellington, Florida, 33414, United States

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Atlanta, Georgia, 30342, United States

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Coeur d'Alene, Idaho, 83814, United States

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Sandpoint, Idaho, 83864, United States

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Aurora, Illinois, 60504, 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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Shrevport, Louisiana, 71106, United States

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Watertown, Massachusetts, 02472, United States

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Chaska, Minnesota, 55318, United States

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Lawrenceville, New Jersey, 08648, United States

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Albuquerque, New Mexico, 87109, United States

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Garden City, New York, 11530, United States

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Mineola, New York, 11501, United States

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Burlington, North Carolina, 27215, 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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Dayton, Ohio, 45439, United States

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Allentown, Pennsylvania, 18103, United States

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Allentown, Pennsylvania, 18106, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15213-3180, United States

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East Providence, Rhode Island, 02914, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29201, United States

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Kingsport, Tennessee, 37660, United States

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Milan, Tennessee, 38358, United States

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Houston, Texas, 77024, United States

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Provo, Utah, 84604, United States

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Chesapeake, Virginia, 23320, United States

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Seattle, Washington, 98104, United States

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Menomonee Falls, Wisconsin, 53051, United States

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Antwerp, 2020, Belgium

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Brussels, 1070, Belgium

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Kortrijk, 8500, Belgium

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Tessenderlo, 3980, Belgium

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Salvador, Estado de Bahia, 40420-000, 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, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

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Campinas, São Paulo, 13084-882, Brazil

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São Paulo, São Paulo, 04039-901, Brazil

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São Paulo, São Paulo, 04262-000, Brazil

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Calgary, Alberta, T2V 4R6, Canada

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Edmonton, Alberta, T5H 3V9, Canada

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Victoria, British Columbia, V8V 3N1, Canada

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Saint John, New Brunswick, E2L 3J8, Canada

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Kitchener, Ontario, N2N 2B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M6A 3B5, Canada

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Montreal, Quebec, H2X 1N8, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Montreal, Quebec, H3S 1Z1, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Rancagua, Región del Libertador General Bernardo O’Higgins, 2820945, Chile

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Port Montt, 5480000, Chile

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Santiago, Chile

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Bogota, Cundinamarca, 0, Colombia

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Bogota, Cundinamarca, Colombia

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Alajuela, Alajuela Province, Costa Rica

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Cartago, Cartago Province, Costa Rica

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San José, Provincia de San José, Costa Rica

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Hradec Králové, 500 02, Czechia

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Jablonec nad Nisou, 466 60, Czechia

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Jindřichův Hradec, 377 38, Czechia

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Ostrava, 708 52, Czechia

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Prague, 180 00, Czechia

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Aalborg, 9100, Denmark

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Aarhus N, 8200, Denmark

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Glostrup Municipality, 2600, Denmark

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Herlev, 2730, Denmark

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Kolding, 6000, Denmark

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Nykoebing Falster, 4800, Denmark

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Roskilde, 4000, Denmark

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Ahaus, 41683, Germany

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Alzey, 55232, Germany

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Berlin, 10787, Germany

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Berlin, 13125, Germany

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Berlin, 13347, Germany

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Karlsruhe, 76199, Germany

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Krumbach, 86381, Germany

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Leipzig, 04105, Germany

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Leipzig, 04109, Germany

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Marburg, 35039, Germany

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Muelheim A.d. Ruhr, 45468, Germany

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München, 81241, Germany

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München, 81925, Germany

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Rosenheim, 83022, Germany

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Athens, Attica, 10552, Greece

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Ioannina, Ipiros, 45001, Greece

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Rio, Patras, 26500, Greece

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Thessaloniki, 56403, Greece

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Debrecen, 4026, Hungary

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Nyíregyháza, 4400, Hungary

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Szeged, 6725, Hungary

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Szentes, 6600, Hungary

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Hyderabad, Andhra Pradesh, 500 001, India

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Hyderabad, Andhra Pradesh, 500 082, India

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Bangalore, Karnataka, 560 034, India

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Jaipur, Rajasthan, 302 004, India

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Vellore, Tamil Nadu, 632 004, India

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Lucknow, Uttar Pradesh, 226003, India

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Latina, 04100, Italy

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Padua, 35128, Italy

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Siena, 53100, Italy

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Batu Caves, Selangor, 68100, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Bergen, 5005, Norway

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Hamar, 2317, Norway

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Lysaker, 1366, Norway

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Oslo, 0264, Norway

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Oslo, NO-0257, Norway

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Sandnes, 4313, Norway

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Lima, Lima Province, L27, Peru

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Surco, Lima region, L33, Peru

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Bialystok, 15-950, Poland

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Bydgoszcz, 85-168, Poland

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Lodz, 91-463, Poland

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Szczecin, 70-11, Poland

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Warsaw, 02-507, Poland

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Arad, 310175, Romania

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Bucharest, 041345, Romania

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Bucharest, 050653, Romania

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Sibiu, 550245, Romania

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Timișoara, 300736, Romania

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Moscow, Russia, 105425, Russia

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Saint Petersburg, Russia, Russia

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Moscow, 101000, Russia

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Moscow, 115516, Russia

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Moscow, 117815, Russia

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Rostov-on-Don, 344022, Russia

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 229899, Singapore

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Bloemfontein, Free State, 9300, South Africa

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Parktown, Gauteng, 2193, South Africa

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Vosloorus, Gauteng, 1475, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

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Cape Town, 8001, South Africa

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Pretoria, 0083, South Africa

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Seoul, Korea, 110-744, South Korea

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Daegu, 705-718, South Korea

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Seoul, 100-380, South Korea

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Seoul, 120-752, South Korea

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Seoul, 136-705, South Korea

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Seoul, 137-040, South Korea

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Getafe, Madrid, 28905, Spain

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Madrid, Madrid, 28046, Spain

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Valencia, Valencia, 46010, Spain

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Bilbao, Vizcaya, 48013, Spain

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Huskvarna, 561 36, Sweden

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Luleå, 97180, Sweden

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Malmo, 205 02, Sweden

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Skövde, 541 30, Sweden

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Stockholm, Sweden

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Frauenfeld, CH-8500, Switzerland

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Lucerne, CH-6000, Switzerland

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Niao-Sung Hsiang, Kaohsiung, 833, Taiwan

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Hualien City, 970, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 100, Taiwan

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Taipei, Taiwan

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Chernivtsi, 58002, Ukraine

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Kharkiv, 61037, Ukraine

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Kyiv, 04053, Ukraine

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Odesa, 65000, Ukraine

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Zaporizhzhia, 69000, Ukraine

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Related Publications (3)

• 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

• Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

  PMID: 35881009 DERIVED

• Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.

  PMID: 21428726 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine; Tolterodine Tartrate

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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 8, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 24, 2015
• Results First Posted: September 3, 2009

Record last verified: 2015-03

Locations

US (41); PL (5); DE (14); GR (4); BE (4); ES (4); SG (2); IT (3); ZA (7); IN (6); CZ (5); CA (11); CL (3); NO (6); RU (6); CH (2); MY (2); UA (5); RO (5); CO (2); HU (4); PE (2); BR (7); SE (5); DK (7); HK (2); TW (5); KR (6)