Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Summary

The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.

Timeline

Start

2007-09

Primary completion

2010-12

Completion

2010-12

Publications

• Background Merskey H, Bugduk N. Classification of chronic pain. Description of chronic pain. Description of chronic pain syndromes and definitions of chronic pain terms. Seattle: IASP, press 1994
• Background Negri E, Bettaglio R, Demartini L, Allegri M, Barbieri M, Miotti D, Paulin L, Buonocore M, Bonezzi C. [Validation of the Italian version of the "Neuropathic Pain Scale" and its clinical applications]. Minerva Anestesiol. 2002 Mar;68(3):95-104. Italian.
• Background Riley J, Ross JR, Rutter D, Wells AU, Goller K, du Bois R, Welsh K. No pain relief from morphine? Individual variation in sensitivity to morphine and the need to switch to an alternative opioid in cancer patients. Support Care Cancer. 2006 Jan;14(1):56-64. doi: 10.1007/s00520-005-0843-2. Epub 2005 Jun 11.
• Background Mucci-LoRusso P, Berman BS, Silberstein PT, Citron ML, Bressler L, Weinstein SM, Kaiko RF, Buckley BJ, Reder RF. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain. 1998;2(3):239-49. doi: 10.1016/s1090-3801(98)90020-9.
• Background Bruera E, Belzile M, Pituskin E, Fainsinger R, Darke A, Harsanyi Z, Babul N, Ford I. Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain. J Clin Oncol. 1998 Oct;16(10):3222-9. doi: 10.1200/JCO.1998.16.10.3222.
• Background Altier N, Dion D, Boulanger A, Choiniere M. Management of chronic neuropathic pain with methadone: a review of 13 cases. Clin J Pain. 2005 Jul-Aug;21(4):364-9. doi: 10.1097/01.ajp.0000125247.95213.53.
• Background Gralow I. Cancer pain: an update of pharmacological approaches in pain therapy. Curr Opin Anaesthesiol. 2002 Oct;15(5):555-61. doi: 10.1097/00001503-200210000-00014.
• Background Farrar JT, Portenoy RK. Neuropathic cancer pain: the role of adjuvant analgesics. Oncology (Williston Park). 2001 Nov;15(11):1435-42, 1445; discussion 1445, 1450-3.
• Background Dirks J, Petersen KL, Rowbotham MC, Dahl JB. Gabapentin suppresses cutaneous hyperalgesia following heat-capsaicin sensitization. Anesthesiology. 2002 Jul;97(1):102-7. doi: 10.1097/00000542-200207000-00015.
• Background Caraceni A, Zecca E, Bonezzi C, Arcuri E, Yaya Tur R, Maltoni M, Visentin M, Gorni G, Martini C, Tirelli W, Barbieri M, De Conno F. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol. 2004 Jul 15;22(14):2909-17. doi: 10.1200/JCO.2004.08.141.
• Background Mercadante S, Arcuri E, Tirelli W, Villari P, Casuccio A. Amitriptyline in neuropathic cancer pain in patients on morphine therapy: a randomized placebo-controlled, double-blind crossover study. Tumori. 2002 May-Jun;88(3):239-42. doi: 10.1177/030089160208800310.
• Background Grond S, Zech D, Diefenbach C, Radbruch L, Lehmann KA. Assessment of cancer pain: a prospective evaluation in 2266 cancer patients referred to a pain service. Pain. 1996 Jan;64(1):107-114. doi: 10.1016/0304-3959(95)00076-3.
• Background Portenoy RK, Foley KM, Inturrisi CE. The nature of opioid responsiveness and its implications for neuropathic pain: new hypotheses derived from studies of opioid infusions. Pain. 1990 Dec;43(3):273-286. doi: 10.1016/0304-3959(90)90025-9.
• Background Chua KS, Reddy SK, Lee MC, Patt RB. Pain and loss of function in head and neck cancer survivors. J Pain Symptom Manage. 1999 Sep;18(3):193-202. doi: 10.1016/s0885-3924(99)00070-6.
• Background Zech DFJ, Grond S, Lynch J, Hertel D, Lehmann KA. Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain. 1995 Oct;63(1):65-76. doi: 10.1016/0304-3959(95)00017-M.
• Background Caraceni A. Clinicopathologic correlates of common cancer pain syndromes. Hematol Oncol Clin North Am. 1996 Feb;10(1):57-78. doi: 10.1016/s0889-8588(05)70327-0.
• Background Elliott KJ. Taxonomy and mechanisms of neuropathic pain. Semin Neurol. 1994 Sep;14(3):195-205. doi: 10.1055/s-2008-1041078. No abstract available.
• Background Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.
• Background Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.
• Background Bennett MI, Simpson KH. Gabapentin in the treatment of neuropathic pain. Palliat Med. 2004 Jan;18(1):5-11. doi: 10.1191/0269216304pm845ra.
• Background Ross JR, Goller K, Hardy J, Riley J, Broadley K, A'hern R, Williams J. Gabapentin is effective in the treatment of cancer-related neuropathic pain: a prospective, open-label study. J Palliat Med. 2005 Dec;8(6):1118-26. doi: 10.1089/jpm.2005.8.1118.
• Background Frampton JE, Foster RH. Pregabalin: in the treatment of postherpetic neuralgia. Drugs. 2005;65(1):111-8; discussion 119-20. doi: 10.2165/00003495-200565010-00011.
• Background Davis MP. What is new in neuropathic pain? Support Care Cancer. 2007 Apr;15(4):363-72. doi: 10.1007/s00520-006-0156-0. Epub 2006 Nov 28.
• Background Sonnett TE, Setter SM, Campbell RK. Pregabalin for the treatment of painful neuropathy. Expert Rev Neurother. 2006 Nov;6(11):1629-35. doi: 10.1586/14737175.6.11.1629.
• Background Reyes-Gibby CC, Shete S, Rakvag T, Bhat SV, Skorpen F, Bruera E, Kaasa S, Klepstad P. Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRM1 and COMT gene. Pain. 2007 Jul;130(1-2):25-30. doi: 10.1016/j.pain.2006.10.023. Epub 2006 Dec 6.
• Background Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep. 1985 Dec;69(12):1375-81.
• Background Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
• Background Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.
• Garassino MC, Piva S, La Verde N, Spagnoletti I, Iorno V, Carbone C, Febbraro A, Bianchi A, Bramati A, Moretti A, Ganzinelli M, Marabese M, Gentili M, Torri V, Farina G. Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PLoS One. 2013;8(4):e59981. doi: 10.1371/journal.pone.0059981. Epub 2013 Apr 5.

Drugs

Indications