drugset / Trial / NCT01340027
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
RandomizedFactorialTriple-blindTreatment
Summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
Timeline
- Start
- 2011-03-29
- Primary completion
- 2012-06-28
- Completion
- 2012-06-28
Publications
- Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 25 mg | Oral |
| Subject | Mirabegron | Other / unclassified | 50 mg | Oral |
| Subject | Solifenacin | Small molecule | 2.5 mg | Oral |
| Subject | Solifenacin | Small molecule | 5 mg | Oral |
| Subject | Solifenacin | Small molecule | 10 mg | Oral |