A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

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

Outcome

Met primary endpoint

paper all combinations with solifenacin 5 or 10 mg significantly improved MVV PMID 24612659 ↗

registry Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg; p = 0.005; LS Mean Difference 17.6 (95% CI 5.4 to 29.8); ANCOVA NCT01340027 ↗

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

Indications