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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History