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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192568
• Other study ID #: OG09002
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2011
• Est. completion date: October 24, 2023

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 24, 2023
• Est. primary completion date: August 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

• 3 years to < 17 years

• Neurogenic bladder

• Neurological condition

• CIC

Exclusion Criteria:

• Have anatomical bladder abnormalities

• Sensitivity to anticholinergics

• Bladder augmentation

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxybutynin
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.

Locations

Country	Name	City	State
United States	Albany Medical College /ID# 236880	Albany	New York
United States	Augusta University Medical Center /ID# 238188	Augusta	Georgia
United States	Children's Hospital Colorado /ID# 237620	Aurora	Colorado
United States	Duke University /ID# 237494	Durham	North Carolina
United States	Cook Children's Med. Center /ID# 237538	Fort Worth	Texas
United States	University of Mississippi Medical Center /ID# 238065	Jackson	Mississippi
United States	Loma Linda University /ID# 236889	Loma Linda	California
United States	Child Hosp of Orange County,CA /ID# 237517	Orange	California
United States	Oregon Health & Science University /ID# 234354	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. Erratum In: J Urol. 2009 Dec;182(6):2985. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of catheterizations without a leaking accident.	The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.	baseline (week 0) up to week 6
Secondary	Average volume of urine collected per catheterization (for Pre-Amendment 3 population only)	The Pre-Amendment 3 population included pediatric patients, from ages 6 years to < 17 years, who had a diagnosis of detrusor overactivity associated with a neurological condition and were using CIC to control bladder function	baseline (week 0) up to week 6
Secondary	Average volume of urine collected at first (morning awakening) catheterization		baseline (week 0) up to week 6
Secondary	Average number of catheterizations per day		baseline (week 0) up to week 6