| A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine |
| 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. |
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment |
| Overactive Bladder |
- Drug: Fesoterodine 8mg
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
- Drug: Fesoterodine 4mg
Oral, 1 tablet per day, 12 weeks duration, 4mg/day
- Drug: Placebo
Oral, 1 tablet per day, 12 weeks duration
|
- Experimental: Fesoterodine 8mg
Intervention: Drug: Fesoterodine 8mg
- Experimental: Fesoterodine 4mg
Intervention: Drug: Fesoterodine 4mg
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
|
| Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1. |
| |
| Completed |
| 2012 |
| November 2012 |
| November 2012 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.
Exclusion Criteria:
- Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Lithuania, Mexico, Norway, Philippines, Poland, Russian Federation, Slovakia, South Africa, Sweden, Taiwan, Ukraine, United Kingdom, United States |
| Austria |
| |
| NCT01302067 |
A0221095
EIGHT |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2014 |
