Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00681356
Status:
COMPLETED
Last Update Posted:
2009-05-04
First Post:
2008-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
Sponsor:
Anesiva, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2009-05
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:
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Detailed Description:
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
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?: