NCT00798434

A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 794 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Placebo	placebo administered orally in the morning or evening.
DRUG	Fesoterodine fumarate	Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-11-26
• Last updated: 2011-12-14
• Results posted: 2011-12-14

Locations

60 sites across 15 countries: Austria, Belgium, Denmark, Finland, Germany, Israel, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom