NCT00681356

Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Anesiva, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Total Knee Arthroplasty (Replacement)

Interventions

Type	Name	Description
DRUG	4975, 15 and 5 mg	Direct instillation into the surgical site
DRUG	Placebo Comparator	Direct instillation into the surgical site
DRUG	4975 - 5 mg	Direct instillation into the surgical site

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2008-05-21
• Last updated: 2009-05-04

Locations

25 sites across 1 country: United States