Optimisation of Hydromorphone Naloxone Ratio for the treatment of pain

• Research type

  Research Study

• Full title

  A confirmatory, placebo-controlled, randomised, double-blind, single dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone.

• IRAS ID

  15746

• Sponsor organisation

  Mundipharma Research GmbH & Co. KG

• Eudract number

  2008-005315-18

• ISRCTN Number

  n/a

• Research summary

  Hydromorphone is a pain killer that belongs to a class of drugs known as opioids (morphine is another opioid). Constipation is the most frequently reported side effect in patients receiving long term opioid therapy and represents a significant clinical problem. It can be so severe that some patients opt to discontinue opioid therapy. Naloxone is an opioid antagonist which when administered orally has a laxative effect and can reduce opioid-induced constipation without reducing the painkilling effect of hydromorphone.The purpose of this study is to investigate whether a hydromorphone/naloxone combination will have a similar painkilling effect with a decrease in constipation in patients with moderate to severe, chronic non-cancer or cancer pain suffering from opioid-induced constipation when compared with hydromorphone alone and to investigate the optimal dose ratio of hydromorphone and naloxone.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/83

• Date of REC Opinion

  9 Sep 2009

• REC opinion

  Further Information Favourable Opinion