NCT00683267

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Anesiva, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement

Detailed description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty

Conditions

• Arthroplasty

Interventions

Type	Name	Description
DRUG	4975, highly purified capsaicin	One dose administered by direct instillation into the surgical site
DRUG	Placebo	One dose administered by direct instillation into the surgical site

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-05-23
• Last updated: 2009-05-04

Locations

10 sites across 1 country: United States