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).

Trial Profile

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2013

At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 15 Feb 2011 Additional safety data will be presented at the 2011 American Academy of Orthopaedic Surgeons Annual Meeting according to a Pacira Pharmaceuticals media release.
    • 14 Jan 2011 Additional results reported in a Pacira Pharmaceuticals media release.
    • 31 Aug 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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