A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension

Trial Profile

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Sep 2014

At a glance

  • Drugs Oxycodone/paracetamol (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Mallinckrodt LLC
  • Most Recent Events

    • 03 May 2014 Tolerability results from a pooled analysis of two phase III trials presented at the 33rd Annual Scientific Meeting of the American Pain Society.
    • 05 Sep 2013 Results presented at PAINWeek, and reported in a Mallinckrodt Pharmaceuticals media release.
    • 05 Sep 2013 In July, the US (FDA accepted for filing the New Drug Application for MNK-795 and granted priority review, according to a Mallinckrodt Pharmaceuticals media release. Data from this study formed part of the application.
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