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

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 Patients”

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.

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.

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

• 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

Primary Measures

• Average Catheterization Urine Volume
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• Catheterizations Without Leakage
  • Time Frame: 14 weeks
    Safety Issue?: No
• Urine Volume After First Awakening
  • Time Frame: 14 weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Watson Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Gary Hoel, RPh, PhD Study Chair Watson Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00224016

Study ID Number: O03010

ClinicalTrials.gov Identifier: NCT00224016

Health Authority: United States: Food and Drug Administration