Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
Information source: Associazione Progetto Oncologia UMAN.A
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain
Intervention: oxycodone (Drug); pregabalin (Drug)
Phase: Phase 2
Sponsored by: Associazione Progetto Oncologia UMAN.A
Official(s) and/or principal investigator(s):
Gabriella Farina, MD, Principal Investigator, Affiliation: Fatebenefratelli and Ophtalmic Hospital
Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: email@example.com
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.
Official title: Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
Pain control rate
Reduction of Break Through Pain number
Record of adverse events
Reduction of allodynia in patients presenting it at T0
Assessing whether COMT and mu blood polymorphisms are associated to response
Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are
the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less
then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often
combined with opioids in the analgesic regimen of patients with neuropathic cancer pain.
This approach is suggested by well-established guidelines, but the analgesic benefit and the
safety of pregabalin and oxycodone in combination is not yet documented.
The aim of this study is to assess the activity and tolerability of the addition of
pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.
Minimum age: 18 Years.
Maximum age: N/A.
- instrumental and clinical diagnosis of every malignant neoplasm
- presence of pain with a neuropathic component in the opinion of the physician
- presence of pain >=4(NRS)
- PS ECOG <3
- written informed consent
- serum creatinine >2mg/ml or creatinine clearance <40 ml/min
- mild or severe hepatic insufficiency
- iatrogenic neuropathy caused by chemotherapeutic agents
- previous allergic reactions to oxycodone and pregabalin
- pregnancy or breastfeeding
Locations and Contacts
Gabriella Farina, MD, Phone: +39 02 6363 2223, Email: firstname.lastname@example.org
Ospedale Fatebenefratelli, Benevento 82100, Italy; Recruiting
Antonio Febbraro, MD, Phone: +39 3403371731, Email: email@example.com
Antonio Febbraro, MD, Principal Investigator
Ospedali Riuniti, Bergamo 24123, Italy; Not yet recruiting
Roberto Labianca, MD, Phone: +39 035269111, Email: RLabianca@ospedaliriuniti.bergamo.it
Roberto Labianca, MD, Principal Investigator
Cecilia Moro, MD, Sub-Investigator
Ospedale S. Orsola, Brescia 25122, Italy; Recruiting
Giordano Beretta, MD, Phone: +39 0302971224, Email: firstname.lastname@example.org
Giordano Beretta, MD, Principal Investigator
Fatebenefratelli and Ophtalmic Hospital, Milano 20121, Italy; Recruiting
Gabriella Farina, MD, Phone: +39 0263632223, Email: email@example.com
Aurora Rizzo, PharmD, Phone: +39 0263632223, Email: firstname.lastname@example.org
Gabriella Farina, MD, Principal Investigator
Marina C Garassino, MD, Sub-Investigator
Ospedale Fatebenefratelli, Roma, Italy; Recruiting
Enrico Breda, MD, Phone: +39 330291335, Email: email@example.com
Enrico Breda, MD, Principal Investigator
Ospedale Serbelloni, Gorgonzola, Milano 29964, Italy; Recruiting
Luciano Isa, MD, Phone: +39 0295707207, Email: firstname.lastname@example.org
Luciano Isa, MD, Principal Investigator
Claudia Carbone, MD, Sub-Investigator
Ospedale Civile di Legnano, Parabiago, Milano 20015, Italy; Recruiting
Elena Collovà, MD, Phone: +39 3478632345, Email: email@example.com
Elena Collovà, MD, Sub-Investigator
Sergio Fava, MD, Principal Investigator
Ospedale Sacro Cuore, Negrar, Verona 37024, Italy; Recruiting
Roberto Magarotto, MD, Phone: +39 0456013111, Email: firstname.lastname@example.org
Roberto Magarotto, MD, Sub-Investigator
Marco Venturini, MD, Principal Investigator
Francesca Coati, Sub-Investigator
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.
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. Epub 2005 Jun 11.
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.
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.
Altier N, Dion D, Boulanger A, Choinière M. Management of chronic neuropathic pain with methadone: a review of 13 cases. Clin J Pain. 2005 Jul-Aug;21(4):364-9.
Gralow I. Cancer pain: an update of pharmacological approaches in pain therapy. Curr Opin Anaesthesiol. 2002 Oct;15(5):555-61.
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. Review.
Dirks J, Petersen KL, Rowbotham MC, Dahl JB. Gabapentin suppresses cutaneous hyperalgesia following heat-capsaicin sensitization. Anesthesiology. 2002 Jul;97(1):102-7.
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.
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.
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):107-14.
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):273-86.
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.
Zech DF, 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.
Caraceni A. Clinicopathologic correlates of common cancer pain syndromes. Hematol Oncol Clin North Am. 1996 Feb;10(1):57-78. Review.
Elliott KJ. Taxonomy and mechanisms of neuropathic pain. Semin Neurol. 1994 Sep;14(3):195-205. Review. No abstract available.
Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. Review.
Attal N, Cruccu G, Haanpää 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.
Bennett MI, Simpson KH. Gabapentin in the treatment of neuropathic pain. Palliat Med. 2004 Jan;18(1):5-11. Review.
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.
Frampton JE, Foster RH. Pregabalin: in the treatment of postherpetic neuralgia. Drugs. 2005;65(1):111-8; discussion 119-20. Review.
Davis MP. What is new in neuropathic pain? Support Care Cancer. 2007 Apr;15(4):363-72. Epub 2006 Nov 28. Review.
Sonnett TE, Setter SM, Campbell RK. Pregabalin for the treatment of painful neuropathy. Expert Rev Neurother. 2006 Nov;6(11):1629-35. Review.
Reyes-Gibby CC, Shete S, Rakvåg 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. Epub 2006 Dec 6.
Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep. 1985 Dec;69(12):1375-81.
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.
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.
Starting date: September 2007
Last updated: January 29, 2009