Fesoterodine Flexible Dose Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Key facts

Study ID

NCT00536484

Run by

Pfizer

People needed

896

Starts

2007-08-01

Expected to finish

2008-03-01

Last updated by the study team

2009-09-15

Who can join

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

You may qualify if…

• Overactive bladder symptoms for greater than or equal to 3 months.
• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
• Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

You may not qualify if…

• Contraindication to fesoterodine (antimuscarinics).
• Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
• 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.

Where it is running

• Pfizer Investigational Site — Chandler, Arizona, United States
• Pfizer Investigational Site — Peoria, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Rancho Cordova, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Englewood, Colorado, United States
• Pfizer Investigational Site — New Britain, Connecticut, United States
• Pfizer Investigational Site — Aventura, Florida, United States
• Pfizer Investigational Site — Bonita Springs, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Lake Worth, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Naples, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — St. Petersburg, Florida, United States
• Pfizer Investigational Site — Stuart, Florida, United States
• Pfizer Investigational Site — Tallahassee, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Evansville, Indiana, United States
• Pfizer Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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