Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

Neurogenic Bladder Clinical Trial

Official title: A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients

Status Completed

Clinical Trial Summary

This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

Clinical Trial Description

This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition ;

Related Conditions & MeSH terms

• Neurogenic Bladder
• Overactive Detrusor
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive

• NCT number: NCT01192568
• Study type: Interventional
• Source: AbbVie
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2011
• Completion date: October 24, 2023