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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2017

At a glance

  • Drugs Oxycodone/naloxone (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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top