Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:32 AM
Study NCT ID:
NCT00850733
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2009-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
516-BOTOX Urinary Incontinence Detrusor
Sponsor:
Veterans Medical Research Foundation
Organization:
Study Overview
Official Title:
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Safety and Efficacy of a Single Treatment With 2 Dose Levels of BOTOX Purified Neurotoxin Complex Followed by a Treatment With BOTOX in Patients With…
Status:
COMPLETED
Status Verified Date:
2009-09
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:
The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| VMRF Project #07366 | None | None | View |