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

Overview

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.

Full Title of Study: “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 Patients”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2007

Detailed Description

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.

Interventions

• Drug: Oxybutynin
  • 1.3, 2.6, 3.9 mg/day transdermal
• Drug: Oxybutynin
  • 5 to 15 mg/day immediate release or extended release tablets, or syrup

Arms, Groups and Cohorts

• Experimental: Oxybutynin Transdermal System
  • Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
• Active Comparator: Oral oxybutynin
  • 5 to 15 mg/day immediate release or extended release tablets, or syrup

Clinical Trial Outcome Measures

Primary Measures

• Average Catheterization Urine Volume
  • Time Frame: 14 weeks
  • Change from baseline in average volume of urine collected by catheterization

Secondary Measures

• 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

Participating in This Clinical Trial

Inclusion Criteria

• Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition; – Use clean intermittent catheterization – On stable dose of oral oxybutynin before participation Exclusion Criteria:

• Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency – Have any medical condition that precludes their participation in the study or may confound the outcome of the study

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Watson Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Gary Hoel, RPh, PhD, Study Chair, Watson Laboratories, Inc.

Citations Reporting on Results

Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. Erratum in: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.