A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain

Trial Profile

A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2017

At a glance

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

    • 28 Nov 2017 Primary endpoint (Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.) has been met, according to an Egalet Corporation media release.
    • 16 Nov 2017 According to an Egalet media release, this study is expected to be completed by year end.
    • 20 May 2017 Trial design presented at the 36th Annual Scientific Meeting of the American Pain Society
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