A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain.

Trial Profile

A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2015

At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Zogenix
  • Most Recent Events

    • 13 Feb 2014 Results have been published in Pain Medicine according to a Zogenix media release. Results were also summarised in the media release.
    • 21 May 2013 An NDA submitted in March 2013 is anticipated to be reviewed by the FDA in the second half of 2013, according to the Q1 2013 financial report released by Zogenix.
    • 07 Dec 2012 Results from this trial were included in a NDA submitted to the US FDA.
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