Journal of Pain and Symptom Management
Volume 39, Issue 2 , Pages 167-179 , February 2010

Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain

  • Jeremy R. Johnson, MB ChB

      Affiliations

    • Severn Hospice, Shrewsbury, Shropshire, United Kingdom
    • ,
  • Mary Burnell-Nugent, MB BChir

      Affiliations

    • St. Luke's Hospice, Turnchapel, Plymouth, United Kingdom
    • ,
  • Dominique Lossignol, MB ChB, MRCG, DRCOG

      Affiliations

    • Association Hospitaliere De Brussels, Centre des Tumeurs de l'ULB, Brussels, Belgium
    • ,
  • Elena Doina Ganae-Motan, MD

      Affiliations

    • Emergency Department, Hospital “Sf. Ioan cel Nou,” Suceava, Romania
    • ,
  • Richard Potts, BSc (Hons), MICR

      Affiliations

    • GW Pharma Ltd. , Ely, Cambridgeshire
    • ,
  • Marie T. Fallon, MB ChB, MD, FRCP (E), FRCP (Glasg)

      Affiliations

    • Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, United Kingdom
    • Corresponding Author InformationAddress correspondence to: Marie T. Fallon, MD, St. Columba’s Hospice Chair of Palliative Medicine, Edinburgh Cancer Research Centre, Crewe Road, Edinburgh EH4 2XR, United Kingdom.

,Accepted 22 June 2009.

  • Image Result

    Study design (Consolidated Standards of Reporting Trials [CONSORT] diagram). ITT=intent to treat.

    Study design (Consolidated Standards of Reporting Trials [CONSORT] diagram). ITT=intent to treat.

  • Image Result

    Exposure to study medication—mean number of sprays per day. SE=standard error.

    Exposure to study medication—mean number of sprays per day. SE=standard error.

  • Image Result

    Pain 0–10 Numerical Rating Scale scores: responder analysis (ITT analysis). aOdds ratio (95% CI) THC:CBD vs. placebo; bFisher’s exact test.

    Pain 0–10 Numerical Rating Scale scores: responder analysis (ITT analysis). aOdds ratio (95% CI) THC:CBD vs. placebo; bFisher’s exact test.

 This study was sponsored by GW Pharma Ltd. All study medication was supplied by GW Pharma Ltd., and it also funded all sites involved in the study by means of per-patient payments based on recruitment. GW Pharma Ltd. has funded J. R. Johnson (primary author) to attend two conferences to present the results of this study.

PII: S0885-3924(09)00787-8

doi: 10.1016/j.jpainsymman.2009.06.008

Journal of Pain and Symptom Management
Volume 39, Issue 2 , Pages 167-179 , February 2010

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