NCT01302054

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.

A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 990 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Fesoterodine 8 mg	Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
DRUG	Placebo	Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-02-23
• Last updated: 2018-12-04
• Results posted: 2013-03-12

Locations

176 sites across 15 countries: United States, Bulgaria, Canada, Czechia, Egypt, Finland, Germany, Hungary, Mexico, Poland, Russia, South Africa, South Korea, Sweden, Ukraine