Equivalence in analgesic efficacy & bowel function taking OXN tablets.
Research type
Research Study
Full title
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.
IRAS ID
156672
Contact name
Adam Ellery
Contact email
Sponsor organisation
Mundipharma Research GmbH & Co. KG
Eudract number
2013-004888-31
Research summary
The aim of this study is to show that the single-tablet in terms of pain and bowel function in the same daily dose, delivers the same effect as the simultaneous use of several of the already approved tablets.
A simplification in pain treatment by introduction of additional dose strengths of OXN PR will improve the therapeutic options for the treating doctor and patient’s adherence to the analgesic treatment, therefore leading to a clinically relevant improvement in pain treatment.
Based on the available data, there is accumulating evidence that OXN PR is efficacious and generally well tolerated in doses up to OXN160/80 mg PR per day. This is a double-blinded, randomized, cross-over study. It will be conducted at approximately 50-60 sites in 5-7 countries and approx. 200 patients will be recruited for this study. The duration of the study is 37 weeks, this includes the extension study.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1033
Date of REC Opinion
6 Aug 2014
REC opinion
Unfavourable Opinion