Clinical Trial: Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric

Brief Summary: This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Detailed Summary: This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.
Sponsor: Watson Pharmaceuticals

Current Primary Outcome: Average Catheterization Urine Volume [ Time Frame: 14 weeks ]

Change from baseline in average volume of urine collected by catheterization


Original Primary Outcome: Measures of incontinence and leakage

Current Secondary Outcome:

  • Catheterizations Without Leakage [ Time Frame: 14 weeks ]
    Percentage of catherizations without leakage
  • Urine Volume After First Awakening [ Time Frame: 14 weeks ]
    Change from baseline in average volume of urine collected after first morning awakening


Original Secondary Outcome: Safety, patch adhesion

Information By: Watson Pharmaceuticals

Dates:
Date Received: September 13, 2005
Date Started: December 2004
Date Completion:
Last Updated: February 7, 2012
Last Verified: February 2012