A Phase II, International, Multi-Centre, Prospective, Randomised, Parallel-Group, Double-Blind, Dose-Ranging, Placebo-Controlled, 12-Week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport 125, 250 or 500 Units) or Placebo Followed by an Optional 6-Month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.
Phase of Trial: Phase II
Latest Information Update: 11 Sep 2013
At a glance
- Drugs Botulinum toxin A (Primary)
- Indications Overactive bladder
- Focus Therapeutic Use
- Sponsors Ipsen
- 18 Oct 2012 Planned number of patients changed from 80 to 301 as reported by European Clinical Trials Database.
- 01 Aug 2012 New source identified and integrated (German Clinical Trials Register: DRKS00004038).
- 04 Jul 2012 European Clinical Trials Database reports status as prematurely ended in Great Britain, Germany, Netherlands and Italy; completed in Belgium and Czech Republic; and ongoing in France and Spain.