A Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Phase II, Dose Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of oral Litoxetine 10mg, 20mg and 40mg Twice Daily (BID) versus placebo in women with Mixed Urinary Incontinence
Phase of Trial: Phase II
Latest Information Update: 10 May 2017
At a glance
- Drugs Litoxetine (Primary)
- Indications Urinary incontinence
- Focus Proof of concept; Therapeutic Use
- Sponsors IXALTIS
- 15 Mar 2017 Status changed from planning to recruiting, according to IXALTIS media release, since it states that first patient from Georgia has entered the study.
- 15 Mar 2017 According to IXALTIS media release, the company has obtained approval from European Health Authorities through the Voluntary Harmonization Procedure (VHP), which will be followed by national authority and ethics approval in France, UK and Poland, and has also obtained approval from Health Canada and Canadian Central Ethics Committee and Health Authorities and Ethics Committee in Georgia to start.
- 02 Jun 2016 New trial record