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
Duration of Study in the UK
1 years, 8 months, 28 days
Research summary
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 participants will have 17 visits to the research site, which will involve routine assessments, completing a diary, blood and urine tests. The duration of the study is 37 weeks, this includes the extension study.
The aim of this study is to show that the single-tablet of oxycodone/naloxone can be effective in treatment of pain and to reduce the side effects of bowel function compared to taking the same drug in multiple tablets simultaneously.
Oxycodone is a powerful painkiller, the highest tablet strength of for oxycodone/naloxone treatment that can be given to patients is the 40/20 mg tablet, which is taken twice a day - i.e. every 12 hours. Daily doses higher than 80/40 mg oxycodone/naloxone can only be achieved by the simultaneous administration of multiple tablets.
This sponsor has received approval to market this drug in many countries. This authorisation includes daily doses of up to 80/40 mg oxycodone/naloxone prolonged release tablets. The approved dose range is sufficient for many patients with severe pain, but it has been shown that there is a need for higher doses.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1108
Date of REC Opinion
26 Jan 2015
REC opinion
Further Information Favourable Opinion