GWCA1103 - Study of Sativex for the Treatment of Cancer Related Pain

• Research type

  Research Study

• Full title

  A two-part, placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy

• IRAS ID

  124695

• Contact name

  Marie Fallon

• Sponsor organisation

  GW Pharma Ltd.

• Eudract number

  2010-022905-17

• Clinicaltrials.gov Identifier

  NCT01424566

• 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 are not gaining relief or benefit from their existing pain medications. This is a Phase III, two-part, placebo-controlled, multicentre study. All participants enrolled into the trial will receive Sativex during one of the parts of the study, but they will not know which part. During another part of the study participants will be assigned to get either Sativex or placebo. In this part of the study, the assignment will be done randomly, and study participants have a 50% chance of getting Sativex or a 50% chance of getting placebo. The study will last up to 11 weeks, and the treatment period is 7 weeks. The study includes 5 study visits at the study clinic and 1 visit via telephone if applicable. Participants will have to make a daily phone call supplying information on pain, sleep, and medicine usage. Other assessments include questionnaires about constipation, satisfaction, suicidal tendencies, as well as monitoring of adverse events, vital signs, electrocardiogram, blood/urine samples and oral examinations. Eligible participants will not be required to stop any of their current treatments or medications. All participants who complete the study will be given the option of entering a 6 month open-label extension study.

• REC name

  Scotland A REC

• REC reference

  13/SS/0028

• Date of REC Opinion

  28 Mar 2013

• REC opinion

  Further Information Favourable Opinion