A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

Completed · Phase 4 · Has a placebo group

Conditions studied: Urinary Bladder, Overactive

In brief

Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

Key facts

Study ID

NCT01302054

Run by

Pfizer

People needed

990

Starts

2011-05-01

Expected to finish

2012-05-01

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of overactive bladder with symptoms for at least 6 months.
• Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
• Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

You may not qualify if…

• Conditions or prior treatment that may also affect bladder function
• Clinically significant urinary tract infection (UTI)
• Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).

Where it is running

• Alabama Internal Medicine, PC — Birmingham, Alabama, United States
• Brown and McCool Gynecology — Fairhope, Alabama, United States
• Radiant Research, Inc. — Chandler, Arizona, United States
• Eclipse Clinical Research — Green Valley, Arizona, United States
• Radiant Research, Inc. — Tucson, Arizona, United States
• Urological Associates of Southern Arizona, PC — Tucson, Arizona, United States
• American Institute of Research — Los Angeles, California, United States
• Moaz Khorsandi, DO — Los Angeles, California, United States
• Urology Group of Southern California — Los Angeles, California, United States
• Institute for Advanced Urology — Los Angeles, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Sierra Clinical Research — Roseville, California, United States
• Superior Research LLC — Sacramento, California, United States
• California Research Foundation — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Advanced Urology, PC — Parker, Colorado, United States
• Thameside Obstetrics/Gynecological Center — Groton, Connecticut, United States
• S.H.E. Medical Associates — Hartford, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Manatee Medical Research Institute, LLC — Bradenton, Florida, United States
• Atlantic Institute of Clinical Research — Daytona Beach, Florida, United States
• SJS Clinical Research — Destin, Florida, United States
• Ocala Urology Specialists — Ocala, Florida, United States
• Renstar Medical Research, Inc. — Ocala, Florida, United States
• Radiant Research, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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