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

Phase 4

Completed

• Conditions: Overactive Detrusor; Neurogenic Bladder
• Interventions: Drug: Oxybutynin; Drug: Placebo

• Registration Number: NCT01192568
• Lead Sponsor: AbbVie

Brief 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

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Study Start: 2011-05-02
• Primary Completion: 2023-08-26
• Study Completion: 2023-10-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• 3 years to < 17 years
• Neurogenic bladder
• Neurological condition
• CIC

Exclusion Criteria

• Have anatomical bladder abnormalities
• Sensitivity to anticholinergics
• Bladder augmentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OL: OTG (Post-Amend 3)	Oxybutynin	Open-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks.
DB: Placebo (Pre-Amend 3)	Placebo	Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.
DB: OTG (Pre-Amend 3)	Oxybutynin	Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6	Baseline (Week 0) up to Week 6	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6	Baseline (Week 0) up to week 6	Pre-Amendment 3: Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data).
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6	Baseline (Week 0) up to Week 6	Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data).
Change From Baseline in Average Number of Catheterizations Per Day at Week 6	Baseline (Week 0) up to Week 6	Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).

Trial Locations

Locations (10)

Loma Linda University /ID# 236889; 🇺🇸 Loma Linda, California, United States

Albany Medical College /ID# 236880; 🇺🇸 Albany, New York, United States

Duke University /ID# 237494; 🇺🇸 Durham, North Carolina, United States

Duplicate_Oregon Health & Science University /ID# 234354; 🇺🇸 Portland, Oregon, United States

Children's Hospital Colorado - Aurora /ID# 237620; 🇺🇸 Aurora, Colorado, United States

Child Hosp of the King's Dtr's /ID# 237799; 🇺🇸 Norfolk, Virginia, United States

Child Hosp of Orange County,CA /ID# 237517; 🇺🇸 Orange, California, United States

Augusta University Medical Center /ID# 238188; 🇺🇸 Augusta, Georgia, United States

University of Mississippi Medical Center /ID# 238065; 🇺🇸 Jackson, Mississippi, United States

Cook Children's Med. Center /ID# 237538; 🇺🇸 Fort Worth, Texas, United States