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A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 2012 |
| Start date | 2011-05 |
| Completion | 2012-11 |
Conditions
- Overactive Bladder
Interventions
- Fesoterodine 8mg
- Fesoterodine 4mg
- Placebo
Primary outcomes
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. — Week 12
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Countries
United States, Argentina, Canada, Chile, Colombia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, Norway, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Sweden, Taiwan, Ukraine, United Kingdom