NCT00224016

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Detrusor Hyperreflexia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-04-01
• Completion: 2008-09-01
• First posted: 2005-09-22
• Last updated: 2012-02-09
• Results posted: 2009-12-23

Locations

23 sites across 1 country: United States