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A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of Q8003 With Oxycodone and Morphine for the Management of Acute Moderate to Severe Postoperative Pain Following Bunionectomy Surgery.

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Trial Profile

A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of Q8003 With Oxycodone and Morphine for the Management of Acute Moderate to Severe Postoperative Pain Following Bunionectomy Surgery.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Apr 2015

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At a glance

  • Drugs Morphine/oxycodone (Primary) ; Morphine; Oxycodone
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 18 Jul 2011 A New Drug Application for Morphine/oxycodone has been submitted to the US FDA based on the results from this trial.
  • 31 Aug 2010 This trial has been discussed at a symposium entitled "Dual Opioid Therapy: Changing the Paradigm" at the 13th World Congree of Pain in Montreal, according to a QRxPharma media release.
  • 04 May 2010 The secondary endpoint's 'Additional treatment required', 'Time-to-additional-treatment', and 'Analgesic consumption' have been met according to additional results reported in a QRxPharma media release.

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