Demonstrate improvment of constipation-subjects on opioid pain therapy

• Research type

  Research Study

• Full title

  A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation and noninferiority in analgesic efficacy in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy taking 50/25 – 80/40 mg twice daily as oxycodone/naloxone prolonged release (OXN PR) tablets compared to subjects taking 50 - 80 mg twice daily oxycodone prolonged release (OxyPR) tablets alone.

• IRAS ID

  72300

• Sponsor organisation

  Mundipharma Research GmbH & Co. KG

• Eudract number

  2010-021995-27

• Research summary

  Opioid bowel dysfunction is an adverse drug reaction associated with oxycodone and other opioid drugs used for pain relief. Its main feature is constipation which often limits the continuous treatment of pain by opioids and is one of the main reasons for insufficient pain therapy in general.Naloxone is an opioid antagonist normally administered by intravenous injection for the treatment of opioid overdose. When this is administered orally in a modified release formulation, first-pass metabolism in the liver prevents nearly all of it from entering the systemic circulation. This means that oral naloxone can reduce opioid-induced constipation by a direct effect on the gut, without it reducing the central pain relieving effects of oxycodone.Previous trials with a combination of modified release oral oxycodone with naloxone showed that in the majority of subjects the days with laxation were significantly increased and the days with other laxative use significantly decreased. Pain control was no different using the oxycodone/naloxone combination or pure oxycodone. The total dose of oxycodone in these studies was up to 80mg per day. In the new study OXN3506, the dose will be increased up to 160mg per day.Study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female adults with non-malignant or malignant pain requiring opioids. It will assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with oxycodone/naloxone prolonged release tablets or oxycodone prolonged release tablets for up to 5 weeks. In the extension phase OXN3506S, which is up to an additional 24 weeks, all subjects will receive oxycodone/naloxone prolonged release tablets.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0325

• Date of REC Opinion

  13 Jul 2011

• REC opinion

  Further Information Favourable Opinion