GWCA0958 - Study of Sativex for the Treatment of Cancer Related Pain

• Research type

  Research Study

• Full title

  GWCA0958: A double blind, randomized, placebo-controlled, parallel group study of Sativex oromucosal spray (Sativex®; Nabiximols) in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

• IRAS ID

  36966

• Contact name

  Marie Fallon

• Sponsor organisation

  GW Pharma Limited

• Eudract number

  2009-016064-36

• ISRCTN Number

  N/A

• Research summary

  This clinical study is being conducted by GW Pharma Ltd to determine the efficacy and safety of the drug Sativex© in relieving pain for participants who have advanced cancer and not gaining relief or benefit from their existing pain medications. This is important research since it will address the question as to whether Sativex has a role to play in helping participants with uncontrolled pain despite having already tried other available pain medications. The main benefit to the participants in this study will be a potential improvement in the level of pain that they normally experience. They may also benefit from gaining knowledge about their health status through study tests and physician assessments, as well as having close monitoring of their pain. This is a Phase III, double-blind, placebo-controlled, parallel-group, multi-centre study. 370 participants who qualify for the study will be randomly assigned to either active drug or placebo (a placebo is a pill that does not contain any drug). Participants will have 50% chance of getting active drug. Participants will be required to take the study treatment for 5 weeks. A randomisation visit will occur within 5-14 days of the screening visit. The double-blind treatment period will last 5 weeks. All participants who complete the study will be given the option of entering a 6-month open-label extension study, otherwise they will be followed for 1 week after completion of study treatment or early withdrawal from the study. Participants will be required to attend up to 5 study visits (4 in clinic and 1 via telephone if applicable), and to make a daily phone call supplying information on pain, sleep, and medicine usage. Other assessments include questionnaires about: constipation, quality of life, depression, and suicidal tendencies as well as monitoring of: adverse events, survival status, vital signs, blood/urine samples and oral examinations.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/90

• Date of REC Opinion

  15 Mar 2010

• REC opinion

  Further Information Favourable Opinion