A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone.

Trial Profile

A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2015

At a glance

  • Drugs Oxycodone/naloxone (Primary) ; Oxycodone
  • Indications Cancer pain; Constipation; Pain
  • Focus Registrational; Therapeutic Use
  • Acronyms TEMPiT
  • Sponsors Mundipharma GmbH
  • Most Recent Events

    • 14 Oct 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
    • 29 Jan 2014 Planned End Date changed from 1 Dec 2013 to 1 Sep 2014 as reported by ClinicalTrials.gov
    • 29 Jan 2014 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov
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