At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Uritos® +1 moredrug
Likely dose
Uritos® 0.1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International, Multicenter, Open-label, Randomized, Comparative Clinical Study of Efficiency and Safety of Medicinal Product Uritos® (Imidafenacin, Film-coated Tablets; 0,1 mg, Kyorin Pharmaceutical Co. Ltd, Japan) and Urotol® (Tolterodine, Film-coated Tablets 2 mg, Zentiva k.s., Czech Republic) for Treatment of Overactive Bladder
In Brief
A Phase 3 clinical trial evaluating Uritos® and Urotol® for Overactive Bladder. Completed, enrolled 300 participants across 11 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesRussia
CollaboratorsSynergy Research Inc.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJul 2016
Primary CompletionAug 2017
Study CompletionSep 2017
First PostedJul 2018
TodayJul 2026
First PostedJul 2, 2018
Enrollment StartJul 18, 2016
Primary CompletionAug 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8 years ago
Interventions
Uritos®drug
film-coated tablets 0.1 mg
Urotol®drug
film coated tablets, 2 mg