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A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps 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

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Trial Profile

A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps 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

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Overactive bladder
  • Focus Therapeutic Use
  • Sponsors Ipsen

Most Recent Events

  • 05 Oct 2021 This trial has been completed in Spain and France (End Date: 15 Dec 2009), according to European Clinical Trials Database record.
  • 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).

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