Portland, Oregon 97239


Purpose:

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.


Study summary:

This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition


Criteria:

Inclusion Criteria: - 3 years to < 17 years - Neurogenic bladder - Neurological condition - CIC Exclusion Criteria: - Have anatomical bladder abnormalities - Sensitivity to anticholinergics - Bladder augmentation


NCT ID:

NCT01192568


Primary Contact:

Study Director
Anna Chan
Allergan Sales, LLC

Clinical Trials Registry Team
Phone: 1-877-277-8566
Email: IR-CTRegistration@allergan.com


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States

Site Coordinator
Phone: 503-494-8216

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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