Official Title: “A Multi-Center, Open-Label, Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and Pharmacokinetics of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients, Followed by a 12-Week Open-Label Safety Extension Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Oxybutynin

Primary Measures

• Measures of incontinence and leakage

Secondary Measures

• Safety, patch adhesion

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 Sponsor: Watson Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Gary Hoel, RPh, PhD  Watson Laboratories, Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

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