NCT00890682

Study of Postoperative Analgesia in Bunionectomy

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.

Detailed description

Following drug study administration, safety and efficacy assessments were conducted

Conditions

• Bunion
• Hallux Valgus

Interventions

Type	Name	Description
DRUG	SKY0402	Local infiltration of 8cc SKY0402
DRUG	Placebo	Local infiltration of 8cc Placebo

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-04-30
• Last updated: 2013-08-05
• Results posted: 2013-08-05

Locations

1 site across 1 country: United States