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.

Trial Profile

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.

Discontinued
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top