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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: fesoterodine fumarate (Drug); placebo (Drug); tolterodine tartrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: 12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

Percent Change From Baseline of UUI Episodes Per 24 Hours.

Change From Baseline in Mean Voided Volume Per Micturition.

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

Percent Change From Baseline of Micturitions Per 24 Hours.

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

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.

Percent Change From Baseline of Urgency Episodes Per 24 Hours.

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.

Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.

Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.

Change From Baseline in Patient Perception of Bladder Condition (PPBC).

Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).

Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult overactive bladder (OAB) patients who present with OAB symptoms, including

urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day Exclusion Criteria:

- 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.

Locations and Contacts

Pfizer Investigational Site, Antwerpen 2020, Belgium

Pfizer Investigational Site, Bruxelles 1070, Belgium

Pfizer Investigational Site, Kortrijk 8500, Belgium

Pfizer Investigational Site, Tessenderlo 3980, Belgium

Pfizer Investigational Site, Puerto Montt 5480000, Chile

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, Alajuela, Costa Rica

Pfizer Investigational Site, Cartago, Costa Rica

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Hradec Kralove 500 02, Czech Republic

Pfizer Investigational Site, Jablonec nad Nisou 466 60, Czech Republic

Pfizer Investigational Site, Jindrichuv Hradec 377 38, Czech Republic

Pfizer Investigational Site, Ostrava 708 52, Czech Republic

Pfizer Investigational Site, Praha 8 180 00, Czech Republic

Pfizer Investigational Site, Aalborg 9100, Denmark

Pfizer Investigational Site, Aarhus N 8200, Denmark

Pfizer Investigational Site, Glostrup 2600, Denmark

Pfizer Investigational Site, Herlev 2730, Denmark

Pfizer Investigational Site, Kolding 6000, Denmark

Pfizer Investigational Site, Nykoebing Falster 4800, Denmark

Pfizer Investigational Site, Roskilde 4000, Denmark

Pfizer Investigational Site, Ahaus 41683, Germany

Pfizer Investigational Site, Alzey 55232, Germany

Pfizer Investigational Site, Berlin 13347, Germany

Pfizer Investigational Site, Berlin 10787, Germany

Pfizer Investigational Site, Berlin 13125, Germany

Pfizer Investigational Site, Karlsruhe 76199, Germany

Pfizer Investigational Site, Krumbach 86381, Germany

Pfizer Investigational Site, Leipzig 04105, Germany

Pfizer Investigational Site, Leipzig 04109, Germany

Pfizer Investigational Site, Marburg 35039, Germany

Pfizer Investigational Site, Muelheim a.d. Ruhr 45468, Germany

Pfizer Investigational Site, Muenchen 81241, Germany

Pfizer Investigational Site, Muenchen 81925, Germany

Pfizer Investigational Site, Rosenheim 83022, Germany

Pfizer Investigational Site, Rio, Patras 26500, Greece

Pfizer Investigational Site, Thessaloniki 56403, Greece

Pfizer Investigational Site, Hong Kong, Hong Kong

Pfizer Investigational Site, Shatin, Hong Kong

Pfizer Investigational Site, Debrecen 4026, Hungary

Pfizer Investigational Site, Nyiregyhaza 4400, Hungary

Pfizer Investigational Site, Szeged 6725, Hungary

Pfizer Investigational Site, Szentes 6600, Hungary

Pfizer Investigational Site, Latina 04100, Italy

Pfizer Investigational Site, Padova 35128, Italy

Pfizer Investigational Site, Siena 53100, Italy

Pfizer Investigational Site, Daegu 705-718, Korea, Republic of

Pfizer Investigational Site, Seoul 100-380, Korea, Republic of

Pfizer Investigational Site, Seoul 137-040, Korea, Republic of

Pfizer Investigational Site, Seoul 136-705, Korea, Republic of

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of

Pfizer Investigational Site, Kuala Lumpur 59100, Malaysia

Pfizer Investigational Site, Bergen 5005, Norway

Pfizer Investigational Site, Hamar 2317, Norway

Pfizer Investigational Site, Lysaker 1366, Norway

Pfizer Investigational Site, Oslo 0264, Norway

Pfizer Investigational Site, Oslo NO-0257, Norway

Pfizer Investigational Site, Sandnes 4313, Norway

Pfizer Investigational Site, Lima L27, Peru

Pfizer Investigational Site, Bialystok 15-950, Poland

Pfizer Investigational Site, Bydgoszcz 85-168, Poland

Pfizer Investigational Site, Lodz 91-463, Poland

Pfizer Investigational Site, Szczecin 70-11, Poland

Pfizer Investigational Site, Warszawa 02-507, Poland

Pfizer Investigational Site, Arad 310175, Romania

Pfizer Investigational Site, Bucuresti 041345, Romania

Pfizer Investigational Site, Bucuresti 050653, Romania

Pfizer Investigational Site, Sibiu 550245, Romania

Pfizer Investigational Site, Timisoara 300736, Romania

Pfizer Investigational Site, Moscow 101000, Russian Federation

Pfizer Investigational Site, Moscow 115516, Russian Federation

Pfizer Investigational Site, Moscow 117815, Russian Federation

Pfizer Investigational Site, Rostov-on-Don 344022, Russian Federation

Pfizer Investigational Site, Singapore 119074, Singapore

Pfizer Investigational Site, Singapore 229899, Singapore

Pfizer Investigational Site, Cape Town 8001, South Africa

Pfizer Investigational Site, Pretoria 0083, South Africa

Pfizer Investigational Site, Madrid 28046, Spain

Pfizer Investigational Site, Valencia 46010, Spain

Pfizer Investigational Site, Huskvarna 561 36, Sweden

Pfizer Investigational Site, Lulea 97180, Sweden

Pfizer Investigational Site, Malmo 205 02, Sweden

Pfizer Investigational Site, Skovde 541 30, Sweden

Pfizer Investigational Site, Stockholm, Sweden

Pfizer Investigational Site, Frauenfeld CH-8500, Switzerland

Pfizer Investigational Site, Luzern 16 CH-6000, Switzerland

Pfizer Investigational Site, Hualien 970, Taiwan

Pfizer Investigational Site, Taichung City 40705, Taiwan

Pfizer Investigational Site, Taipei 100, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Chernivtsi 58002, Ukraine

Pfizer Investigational Site, Kharkiv 61037, Ukraine

Pfizer Investigational Site, Kyiv 04053, Ukraine

Pfizer Investigational Site, Odessa 65000, Ukraine

Pfizer Investigational Site, Zaporizhzhia 69000, Ukraine

Pfizer Investigational Site, Homewood, Alabama 35209, United States

Pfizer Investigational Site, Huntsville, Alabama 35801, United States

Pfizer Investigational Site, Mobile, Alabama 36608, United States

Pfizer Investigational Site, Calgary, Alberta T2V 4R6, Canada

Pfizer Investigational Site, Edmonton, Alberta T5H 3V9, Canada

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 001, India

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 082, India

Pfizer Investigational Site, Athens, Attiki 10552, Greece

Pfizer Investigational Site, Salvador, BA 40420-000, Brazil

Pfizer Investigational Site, Victoria, British Columbia V8V 3N1, Canada

Pfizer Investigational Site, Carmichael, California 95608, United States

Pfizer Investigational Site, Orangevale, California 95662, United States

Pfizer Investigational Site, San Diego, California 92103-6204, United States

Pfizer Investigational Site, Aurora, Colorado 80012, United States

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

Pfizer Investigational Site, Miami, Florida 33186, United States

Pfizer Investigational Site, Wellington, Florida 33414, United States

Pfizer Investigational Site, Bloemfontein, Free State 9300, South Africa

Pfizer Investigational Site, Vosloorus, Gauteng 1475, South Africa

Pfizer Investigational Site, Parktown, Gauteng Province 2193, South Africa

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Coeur D Alene, Idaho 83814, United States

Pfizer Investigational Site, Sandpoint, Idaho 83864, United States

Pfizer Investigational Site, Aurora, Illinois 60504, United States

Pfizer Investigational Site, West Des Moines, Iowa 50266, United States

Pfizer Investigational Site, Ioannina, Ipiros 45001, Greece

Pfizer Investigational Site, Newton, Kansas 67114, United States

Pfizer Investigational Site, Niao-Sung Hsiang, Kaohsiung 833, Taiwan

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Seoul, Korea 110-744, Korea, Republic of

Pfizer Investigational Site, Durban, Kwa Zulu Natal 4001, South Africa

Pfizer Investigational Site, Pietermaritzburg, Kwa Zulu Natal 3201, South Africa

Pfizer Investigational Site, Surco, Lima L33, Peru

Pfizer Investigational Site, Shrevport, Louisiana 71106, United States

Pfizer Investigational Site, Getafe, Madrid 28905, Spain

Pfizer Investigational Site, Watertown, Massachusetts 02472, United States

Pfizer Investigational Site, Chaska, Minnesota 55318, United States

Pfizer Investigational Site, Saint John, New Brunswick E2L 3J8, Canada

Pfizer Investigational Site, Lawrenceville, New Jersey 08648, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87109, United States

Pfizer Investigational Site, Garden City, New York 11530, United States

Pfizer Investigational Site, Mineola, New York 11501, United States

Pfizer Investigational Site, Burlington, North Carolina 27215, United States

Pfizer Investigational Site, Concord, North Carolina 28025, United States

Pfizer Investigational Site, Huntersville, North Carolina 28078, United States

Pfizer Investigational Site, Dayton, Ohio 45439, United States

Pfizer Investigational Site, Kitchener, Ontario N2N 2B9, Canada

Pfizer Investigational Site, Toronto, Ontario M4N 3M5, Canada

Pfizer Investigational Site, Toronto, Ontario M6A 3B5, Canada

Pfizer Investigational Site, Allentown, Pennsylvania 18103, United States

Pfizer Investigational Site, Allentown, Pennsylvania 18106, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15212, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213-3180, United States

Pfizer Investigational Site, Montreal, Quebec H2X 1N8, Canada

Pfizer Investigational Site, Montreal, Quebec H3S 1Z1, Canada

Pfizer Investigational Site, Montréal, Quebec H2X 3J4, Canada

Pfizer Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada

Pfizer Investigational Site, Rio de Janeiro, RJ CEP 20551-030, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90470-340, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90020-090, Brazil

Pfizer Investigational Site, Jaipur, Rajasthan 302 004, India

Pfizer Investigational Site, East Providence, Rhode Island 02914, United States

Pfizer Investigational Site, Moscow, Russia 105425, Russian Federation

Pfizer Investigational Site, St. Petersburg, Russia, Russian Federation

Pfizer Investigational Site, Campinas, SP 13084-882, Brazil

Pfizer Investigational Site, São Paulo, SP 04039-901, Brazil

Pfizer Investigational Site, São Paulo, SP 04262-000, Brazil

Pfizer Investigational Site, Batu Caves, Selangor 68100, Malaysia

Pfizer Investigational Site, Charleston, South Carolina 29425, United States

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Vellore, Tamil Nadu 632 004, India

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States

Pfizer Investigational Site, Milan, Tennessee 38358, United States

Pfizer Investigational Site, Houston, Texas 77024, United States

Pfizer Investigational Site, Provo, Utah 84604, United States

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226003, India

Pfizer Investigational Site, Rancagua, VI Región 2820945, Chile

Pfizer Investigational Site, Chesapeake, Virginia 23320, United States

Pfizer Investigational Site, Bilbao, Vizcaya 48013, Spain

Pfizer Investigational Site, Seattle, Washington 98104, United States

Pfizer Investigational Site, Menomonee Falls, Wisconsin 53051, United States

Additional Information

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

Starting date: April 2007
Last updated: March 4, 2015

Page last updated: August 23, 2015

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