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.
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Topical gel
Loma Linda University /ID# 236889
Loma Linda, California, United States
Child Hosp of Orange County,CA /ID# 237517
Orange, California, United States
Children's Hospital Colorado - Aurora /ID# 237620
Aurora, Colorado, United States
Augusta University Medical Center /ID# 238188
Augusta, Georgia, United States
University of Mississippi Medical Center /ID# 238065
Jackson, Mississippi, 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
Cook Children's Med. Center /ID# 237538
Fort Worth, Texas, United States
Child Hosp of the King's Dtr's /ID# 237799
Norfolk, Virginia, United States
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at 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.
Time frame: Baseline (Week 0) up to Week 6
Change From Baseline in Average Volume of Urine Collected Per Catheterization at 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).
Time frame: Baseline (Week 0) up to week 6
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at 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).
Time frame: Baseline (Week 0) up to Week 6
Change From Baseline in Average Number of Catheterizations Per Day at Week 6
Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).
Time frame: Baseline (Week 0) up to Week 6
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