Evaluation of Analgesia and Side Effects (EASE) Study

• Research type

  Research Study

• Full title

  A double-blind, double-dummy, parallel group, randomised study to compare the efficacy and tolerability of oxycodone/naloxone prolonged release (OXN PR) and codeine/paracetamol in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis

• IRAS ID

  8398

• Contact name

  Michael Serpell

• Sponsor organisation

  Napp Pharmaceuticals Limited

• Eudract number

  2008-002426-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Oxycodone is a pain killer that belongs to a class of drugs known as opioids (morphine is another opioid). Oxycodone was launched in the UK in January 2000 as a prolonged release formulation (Oxycontin©) and is authorised for the treatment of moderate to severe pain.Although highly effective, a common side effect of the use of opioids is constipation. Constipation can be very uncomfortable for the patient and in some cases it can be so severe that patients opt to discontinue therapy. Oxycodone / naloxone prolonged release (OXN PR) tablets have been developed in order to combine the analgesic effect of oxycodone with the opioid antagonistic property of the drug naloxone which prevents the onset of opioid-induced constipation without altering the analgesic effect of oxycodone.OXN PR was launched in Germany in 2007.The purpose of this study is to demonstrate that OXN PR is as good as the commonly used analgesic, codeine / paracetamol combination tablets, in the treatment of pain associated with low back pain or osteoarthritis.The subjects will be put into 2 groups and each group will be given a different treatment.There will be approximately 244 subjects in this study, comprised of males and females aged 18 years and over who are currently taking codeine/paracetamol combination tablets. The total duration of the study treatment is approximately 17 weeks.

• REC name

  Scotland A REC

• REC reference

  08/MRE00/91

• Date of REC Opinion

  19 Dec 2008

• REC opinion

  Further Information Favourable Opinion