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

• Status: Recruiting
• Trial end date: 2022-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan; Watson Pharmaceuticals
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• 3 years to < 17 years

• Neurogenic bladder

• Neurological condition

• CIC

Exclusion Criteria:

• Have anatomical bladder abnormalities

• Sensitivity to anticholinergics

• Bladder augmentation