Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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

Key facts

Study ID

NCT00611026

Run by

Pfizer

People needed

2417

Starts

2008-02-01

Expected to finish

2009-10-01

Last updated by the study team

2011-02-02

Who can join

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

You may qualify if…

• Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
• Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

You may not qualify if…

• Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
• Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
• Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Montgomery, Alabama, United States
• Pfizer Investigational Site — Chandler, Arizona, United States
• Pfizer Investigational Site — Peoria, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Clovis, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Upland, California, United States
• Pfizer Investigational Site — Vista, California, United States
• Pfizer Investigational Site — Westlake Village, California, United States
• Pfizer Investigational Site — Englewood, Colorado, United States
• Pfizer Investigational Site — New London, Connecticut, United States
• Pfizer Investigational Site — Bonita Spring, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Lake Worth, Florida, United States
• Pfizer Investigational Site — Leesburg, Florida, United States
• Pfizer Investigational Site — Longwood, Florida, United States
• Pfizer Investigational Site — Enterprise, Alabama, United States

Full record on ClinicalTrials.gov

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