A Two-part, Multicenter, Dose-titration Study Evaluating Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for Treatment of Detrusor Overactivity Associated Neurological Condition in Pediatric Patients
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- STATUS
- Recruiting
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- End date
- Dec 30, 2023
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- participants needed
- 58
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- sponsor
- AbbVie
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.
Description
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
Details
| Condition | Overactive Detrusor, Neurogenic Bladder |
|---|---|
| Treatment | Oxybutynin |
| Clinical Study Identifier | NCT01192568 |
| Sponsor | AbbVie |
| Last Modified on | 18 October 2022 |
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