A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 [bupivacaine] for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy.

Trial Profile

A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 [bupivacaine] for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy.

Completed
Phase of Trial: Phase II

Latest Information Update: 05 Aug 2013

At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Pacira Pharmaceuticals
  • Most Recent Events

    • 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.
    • 22 Nov 2010 Primary endpoint 'Pain-intensity' has been met
    • 19 Oct 2010 Results presented at the 2010 Annual Meeting of the American Society of Anesthesiologists.
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