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

Who is this study for? Child patients with Neurogenic Bladder
What treatments are being studied? Oxybutynin
Status: Completed
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 16
Healthy Volunteers: f
View:

• 3 years to \< 17 years

• Neurogenic bladder

• Neurological condition

• CIC

Locations
United States
California
Loma Linda University /ID# 236889
Loma Linda
Child Hosp of Orange County,CA /ID# 237517
Orange
Colorado
Children's Hospital Colorado - Aurora /ID# 237620
Aurora
Georgia
Augusta University Medical Center /ID# 238188
Augusta
Mississippi
University of Mississippi Medical Center /ID# 238065
Jackson
North Carolina
Duke University /ID# 237494
Durham
New York
Albany Medical College /ID# 236880
Albany
Oregon
Duplicate_Oregon Health & Science University /ID# 234354
Portland
Texas
Cook Children's Med. Center /ID# 237538
Fort Worth
Virginia
Child Hosp of the King's Dtr's /ID# 237799
Norfolk
Time Frame
Start Date: 2011-05-17
Completion Date: 2023-10-24
Participants
Target number of participants: 52
Treatments
Experimental: DB: OTG (Pre-Amend 3)
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.
Experimental: OL: OTG (Post-Amend 3)
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.
Placebo_comparator: DB: Placebo (Pre-Amend 3)
Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov