A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of SKY0402 Via Local Infiltration for Prolonged Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty.
Phase of Trial: Phase II
Latest Information Update: 19 Sep 2013
At a glance
- Drugs Bupivacaine (Primary) ; Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 19 Sep 2013 Results reported in a Pacira Pharmaceuticals media release and presented at the Marshall Steele 7th Annual Orthopedic and Spine Summit, according to the media release.
- 21 Apr 2012 Additional trial locations (Germany and Denmark) added as reported by European Clinical Trials Database.
- 15 Dec 2010 According to a Pacira Pharmaceuticals Inc media release, the US FDA has accepted the NDA for Exparel [bupivacaine] for the treatment of postoperative pain.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History