Trials / Completed
CompletedNCT01093534
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 547 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.
Detailed description
Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching solifenacin placebo tablet |
| DRUG | solifenacin | Tablet for oral administration |
Timeline
- Start date
- 2010-01-19
- Primary completion
- 2011-06-23
- Completion
- 2011-06-23
- First posted
- 2010-03-26
- Last updated
- 2024-12-03
- Results posted
- 2014-04-07
Locations
79 sites across 20 countries: United States, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Norway, Poland, Romania, Russia, Slovakia, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01093534. Inclusion in this directory is not an endorsement.