drugset / Trial / NCT03059134

Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

NCT03059134

Phase 3 Completed 168 enrolled Buddhist Tzu Chi General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial compared the therapeutic effects and adverse events (AEs) in overactive bladder (OAB) patients receiving different combination of mirabegron and antimuscarinics. Methods: This is a prospective randomized study. OAB patients received mirabegron 25 mg (M25) daily for one month (1M) and then were randomized as group 1: to continue M25, group 2: to mirabegron 50 mg, group 3: to shift to solifenacin 5 mg (S5) and group 4: to combine M25 and S5 for further 2 months (totally 3 months, 3M). Efficacy and AEs were evaluated. At the end of 3M, the preferred option for future treatment was investigated.

Timeline

Start
2015-04-28
Primary completion
2016-04-27
Completion
2016-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirabegron Other / unclassified 25 mg
Subject Mirabegron Other / unclassified 50 mg

Indications