NCT00656578

Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of a Single Intraoperative Administration of 4975 in Patients Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Anesiva, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy. Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the US. A dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. Upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo. After the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. While at the clinical study site, patients will undergo safety and efficacy assessments. After discharge, patients will report pain severity daily through Day 14 via an interactive voice response system (IVRS). Also, safety and patient-reported outcome assessments will be performed at the Day 14 (Week 2) and Day 28 (Week 4) clinic visits.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	4975	Single dose, solution
DRUG	Placebo	Single dose, solution

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2008-04-11
• Last updated: 2009-05-04

Locations

6 sites across 1 country: United States