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

• Research type

  Research Study

• Full title

  GWCA0701 - A double blind, randomized, placebo controlled, parallel group dose-range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. (Known as the SPRAY Study)

• IRAS ID

  12057

• Contact name

  Stephen Crow

• Sponsor organisation

  GW Pharma Limited

• Eudract number

  2007-005225-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00530764

• Research summary

  In this study we wish to find out the effective dose of GW Pharma Ltd??s medicine, Sativex©, in relieving pain for patients who are suffering from advanced cancer and not gaining relief or benefit from their existing pain medications. Sativex will be compared to a dummy medicine (placebo) that contains no active ingredient. To be eligible for the study subjects must be 18 years old or older. Main key inclusion criteria (not complete):Advanced active cancer for which there is no known curative therapy. A clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. Receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). Main key exclusion criteria (not complete):Receiving or due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. This is a nine week (5 to 14 day baseline, five week treatment period, including a one week titration period, followed by a 2 week follow up visit), dose ranging study aiming to determine the effective dose range of Sativex in the relief of Cancer Pain. The trial design is randomised and placebo controlled. However, there is a 75% chance a subject will receive Sativex during the trial. The trial drug is used as an adjuvant therapy, during treatment subjects are allowed to continue taking their current analgesic therapy.During the study subjects will be asked to make a daily phone call supplying information on pain scores, sleep disruption scores, IMP and opioid usage. Estimated Enrollment: 336Study Start Date in the UK: April 2009Estimated Study Completion Date: April 2010

• REC name

  Scotland A REC

• REC reference

  08/MRE00/112

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Favourable Opinion