Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224016
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-09-13
Brief Title:
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Sponsor:
Watson Pharmaceuticals
Organization:
Watson Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Open-Label OL Active-Controlled Dose-Titration Study Evaluating the Safety Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition eg spina bifida that contributes to their overactive bladder
Detailed Description:
This study will use a multicenter randomized open-label active-controlled dose-titration parallel group design in approximately pediatric patients with detrusor overactivity associated with a neurological condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None