Status:
COMPLETED
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Lead Sponsor:
AbbVie
Conditions:
Overactive Detrusor
Neurogenic Bladder
Eligibility:
All Genders
3-16 years
Phase:
PHASE4
Brief 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 wil...
Detailed Description
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
Eligibility Criteria
Inclusion
- 3 years to \< 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Exclusion
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Key Trial Info
Start Date :
May 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01192568
Start Date
May 17 2011
End Date
October 24 2023
Last Update
September 4 2024
Active Locations (10)
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1
Loma Linda University /ID# 236889
Loma Linda, California, United States, 92354
2
Child Hosp of Orange County,CA /ID# 237517
Orange, California, United States, 92868
3
Children's Hospital Colorado - Aurora /ID# 237620
Aurora, Colorado, United States, 80045
4
Augusta University Medical Center /ID# 238188
Augusta, Georgia, United States, 30912-0004