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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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