Oxybutynin Gel for Pediatric Overactive Bladder

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Allergan

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a skin-applied gel medicine for children with bladder issues caused by nerve problems. The gel helps relax the bladder muscles to reduce overactivity. Children will use the gel for a few months, with doses adjusted based on their response.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for children aged 3 to less than 17 with an overactive bladder due to a neurogenic condition. They must be able to perform clean intermittent catheterization (CIC). Children cannot participate if they have sensitivity to anticholinergics, bladder augmentation, or anatomical bladder abnormalities.

Inclusion Criteria

You must be between 3 and 16 years old.

You have a bladder issue related to nerve problems.

You have a neurological condition.

See 1 more

Exclusion Criteria

You have physical abnormalities in your bladder.

You have had surgery to enlarge your bladder.

You are sensitive to anticholinergic medications.

Treatment Details

Interventions

Oxybutynin (Antimuscarinic Agent)

Trial OverviewThe study tests Oxybutynin Chloride 10% Topical Gel's safety and effectiveness in managing overactive bladders in children with neurogenic conditions. Treatment starts at 0.75 g of gel per day for two weeks, with possible dose adjustments after that based on response and tolerability for a total of 14 weeks.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: OL: OTG (Post-Amend 3)Experimental Treatment1 Intervention

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.

Group II: DB: OTG (Pre-Amend 3)Experimental Treatment1 Intervention

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.

Group III: DB: Placebo (Pre-Amend 3)Placebo Group1 Intervention

Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Oxybutynin is already approved in Canada for the following indications: