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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity.

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Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2020

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Neurogenic bladder; Overactive bladder; Urinary incontinence
  • Focus Registrational; Therapeutic Use
  • Sponsors Allergan

Most Recent Events

  • 31 Jan 2017 Results of post-hoc analysis (n=195) of patients who received only 200U dose of onabotulinumtoxinA during either of the two 52-week, phase 3 studies (NCT00311376 and NCT00461292) and the long-term extension study (NCT00876447), published in the BJU International journal.
  • 15 Apr 2016 Results of a pooled post-hoc analysis from this and other two trials (see profile 199696 and 199739) published in the Journal of Urology
  • 27 Sep 2013 Pooled analysis published in the Advances in Therapy.

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