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

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Detrusor, Neurogenic Bladder

In brief

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.

Key facts

Study ID

NCT01192568

Run by

AbbVie

People needed

52

Starts

2011-05-17

Expected to finish

2023-10-24

Last updated by the study team

2024-09-04

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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