Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335660
Status:
TERMINATED
Last Update Posted:
2008-02-25
First Post:
2006-06-08
Brief Title:
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
Sponsor:
Avera Pharmaceuticals
Organization:
Avera Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
Status:
TERMINATED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Animal Safety Data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effects of AV608 a neurokinin 1 NK-1 antagonist in subjects with Idiopathic Detrusor Overactivity
Detailed Description:
This is a Phase 2 randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial
Eligible subjects will complete a baseline urodynamic assessment All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo At the end of the treatment period subjects will complete a second urodynamic assessment
Eligible subjects will complete a baseline urodynamic assessment All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo At the end of the treatment period subjects will complete a second urodynamic assessment
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