Subjects with chronic moderate to severe pain related to cancer

• Research type

  Research Study

• Full title

  Efficacy, safety, and tolerability of oral GRT6005 versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer.

• IRAS ID

  110833

• Contact name

  Sam Ahmedzai

• Sponsor organisation

  Grünenthal GmbH

• Eudract number

  2012-001316-35

• Research summary

  Moderate to severe pain in cancer patients is usually treated with drugs like morphine, which are known as opioid drugs. A type of pain called neuropathic, which is caused by nerve damage, often does not respond well to morphine. A new opioid drug with the scientific name GRT6005 has been developed that works like morphine but possibly has advantages, specifically it may work better on neuropathic pain. The main aim of this study is to find out whether GRT6005, which is given once daily by mouth, can treat cancer pain as well as morphine, also given once daily by mouth. A secondary aim is to see if the side-effects of GRT6005 are better than those caused by morphine. Another aim is to investigate how the body takes up GRT6005 into the blood, how it is distributed and broken down, and how the substance is eliminated. It is planned that about 514 patients, aged 18 years or older and with moderate to severe chronic pain due to cancer, will be randomised to receive the trial medication (GRT6005) or oral morphine. During the trial period patients will be able to receive fast-acting oral morphine as a rescue medication, regardless of which study drug they are receiving. This study will be performed in about 110 sites in 16 different countries. The trial for each patient will take up to 10 weeks. During that period the doses of both drugs will be varied according to patients?? pain levels. The patient will have to come to the trial centre a total of 7 times during the trial; they will also be contacted 6 times by telephone. In consenting patients, we will do further studies on their blood to find out if there are genetic factors fluncing pain control and side effects with GRT6005 and morphine.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0722

• Date of REC Opinion

  11 Dec 2012

• REC opinion

  Further Information Favourable Opinion