GWCA0999 - Follow on study of Sativex for Cancer Related Pain

• Research type

  Research Study

• Full title

  GWCA0999: A multicentre, non-comparative, follow-on study to assess the long term safety of Sativex oromucosal spray (Sativex®; Nabiximols) therapy in patients with cancer related pain.

• IRAS ID

  44522

• Contact name

  Marie Fallon

• Sponsor organisation

  GW Pharma Limited

• Eudract number

  2009-016529-32

• ISRCTN Number

  N/A

• Research summary

  This clinical study is being conducted by GW Pharma Ltd to evaluate the safety and maintenance of effect of long-term therapy of the drug Sativex© in relieving pain for participants who have advanced cancer. The study provides continued availability of Sativex to participants who completed the preceding double-blind study: GWCA0958. 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 non-comparative, follow-on, multi-centre study. There is no formal sample size for this study. All participants who complete the double-blind study (GWCA0958) will be considered for enrolment and assigned to the active drug. Participants will be required to take the study treatment for 6 months and they will be followed up 1 week after completion of study treatment or early withdrawal from the study. Participants will be required to attend up to 9 study visits (8 in clinic and 1 via telephone if applicable), and to make a weekly phone call supplying information on pain, sleep disruption and study medication usage. Other assessments include questionnaires about suicidal tendencies and quality of life as well as monitoring of: adverse events, vital signs, blood/urine samples and oral examinations.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/34

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Favourable Opinion