drugset / Trial / NCT03575702

Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.

NCT03575702

Phase 3 Completed 300 enrolled R-Pharm Synergy Research Group · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Objective of this study was confirmation on non-inferiority and validation of similar safety profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with other product from m-cholinergic antagonists group Urotol® (Tolterodine).

Timeline

Start
2016-07-18
Primary completion
2017-08-01
Completion
2017-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Imidafenacin Small molecule 0.1 mg Oral
Comparator Tolterodine Small molecule 2 mg Oral

Indications