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 a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity.

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 a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity.

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2017

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 199731 and 199696) published in the Journal of Urology
    • 27 Sep 2013 Pooled analysis published in Advances in Therapy.
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