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A randomised, double-blind, double-dummy, cross-over multicenter study to demonstrate equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg PR, OXN80/40 mg PR) twice daily compared to the identical daily dose taken as a combination of lower tablet strengths in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy.

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Trial Profile

A randomised, double-blind, double-dummy, cross-over multicenter study to demonstrate equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg PR, OXN80/40 mg PR) twice daily compared to the identical daily dose taken as a combination of lower tablet strengths in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2021

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At a glance

  • Drugs Naloxone/oxycodone (Primary)
  • Indications Pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Mundipharma GmbH

Most Recent Events

  • 03 Nov 2016 Status changed from active, no longer recruiting to completed.
  • 30 Sep 2016 Results of post-hoc analysis evaluating outcome in cancer patients presented at the 16th World Congress on Pain
  • 30 Sep 2016 Results assessing long-term safety and efficacy presented at the 16th World Congress on Pain.

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