A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy.

Trial Profile

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 May 2016

At a glance

  • Drugs Oxycodone/naloxone (Primary) ; Oxycodone
  • Indications Back pain; Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms CONVERGE
  • Sponsors Purdue Pharma L.P
  • Most Recent Events

    • 06 Nov 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record. .
    • 31 Jul 2014 Planned End Date changed from 1 May 2015 to 1 Oct 2014 as reported by ClinicalTrials.gov record.
    • 31 Jul 2014 Planned primary completion date changed from 1 Mar 2015 to 1 Oct 2014 as reported by ClinicalTrials.gov record.
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