NCT01192568

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Overactive Detrusor
• Neurogenic Bladder

Interventions

Type	Name	Description
DRUG	Oxybutynin	10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
DRUG	Placebo	Topical gel

Timeline

• Start date: 2011-05-17
• Primary completion: 2023-08-29
• Completion: 2023-10-24
• First posted: 2010-09-01
• Last updated: 2024-09-04
• Results posted: 2024-09-04

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study