Buprenorphine transdermal system in adults with chronic low back pain: A randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase

Clinical Therapeutics

Volumn 32, Issue 5, 2010, Pages 844-860

  Gordon, Allan ^a   Callaghan, Denis ^b   Spink, Donald ^c   Cloutier, Christian ^d   Dzongowski, Peter ^e   O'Mahony, William ^f   Sinclair, Duncan ^b   Rashiq, Saifudin ^g   Buckley, Norm ^h   Cohen, Geoffrey ⁱ   Kim, James ^j   Boulanger, Aline ^k   Piraino, Paula S ^l   Eisenhoffer, John ^l   Harsanyi, Zoltan ^l   Darke, Andrew C ^l   Michalko, Kenneth J ^l  

^a Wasser Pain Management Centre   (Canada)

^b Private Practice   (Canada)

^c Brookdale Research   (Canada)

^d CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

^e London East Medical Centre   (Canada)

^f Corunna Medical Services Ltd ^*  (Canada)

^g UNIVERSITY OF ALBERTA   (Canada)

^h MCMASTER UNIVERSITY   (Canada)

ⁱ Winston Churchill Medical Centre   (Canada)

^j Private practice   (Canada)

^k CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^l PURDUE PHARMA L P   (United States)

more..

Author keywords

Buprenorphine; Chronic noncancer pain; Low back pain; Transdermal system

Indexed keywords

BUPRENORPHINE; PARACETAMOL;

ADULT; ARTICLE; ASTHENIA; CHRONIC PAIN; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; PAIN ASSESSMENT; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SKIN MANIFESTATION; SOMNOLENCE; SWEATING; TREATMENT OUTCOME; VISUAL ANALOG SCALE; VOMITING; XEROSTOMIA;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; ANALGESICS, OPIOID; BUPRENORPHINE; CHRONIC DISEASE; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HUMANS; LOW BACK PAIN; MALE; MIDDLE AGED;

EID: 77954766869     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.04.018     Document Type: Article

References (49)

1. Musculoskeletal diseases Statistics Canada, Accessed December 9, 2008. http://www.statcan.gc.ca/pub/82-619-m/2006003/4053542-eng.htm.
2. Woolf AD, Pfleger B Burden of major musculoskeletal conditions. Bull World Health Organ. 2003, 81:646-656.
3. Asche CV, Kirkness CS, McAdam-Marx C, Fritz JM The societal costs of low back pain: Data published between 2001 and 2007. J Pain Palliat Care Pharmacother. 2007, 21:25-33.
4. Dagenais S, Caro J, Haldeman DC A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008, 8:8-20.
5. Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society [published correction appears in Ann Intern Med. 2008;148:247-248]. Ann Intern Med. 2007, 147:478-491. Clinical Efficacy Assessment Subcommittee of the American College of Physicians and the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel.
6. Cancer Pain Relief, With a Guide to Opioid Availability 1996, World Health Organization, World Health Organization, Geneva, Switzerland. 2nd ed.
7. Arkinstall W, Sandler A, Goughnour B, et al. Efficacy of controlled-release codeine in chronic non-malignant pain: A randomized, placebo-controlled clinical trial. Pain. 1995, 62:169-178.
8. Moulin DE, lezzi A, Amireh R Randomised trial of oral morphine for chronic non-cancer pain. Lancet. 1996, 347:143-147.
9. Caldwell JR, Hale ME, Boyd RE, et al. Treatment of osteoarthritis pain with controlled release oxycodone or fixed combination oxycodone plus acetaminophen added to nonsteroidal antiinflammatory drugs: A double blind, randomized, multicenter, placebo controlled trial. J Rheumatol. 1999, 26:862-869.
10. Peloso PM, Bellamy N, Benson W, et al. Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee. J Rheumatol. 2000, 27:764-771.
11. Roth SH, Fleischmann RM, Burch FX, et al. Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: Placebo-controlled trial and long-term evaluation. Arch Intern Med. 2000, 160:853-860.
12. Watson CP, Babul N Efficacy of oxycodone in neuropathic pain: A randomized trial in postherpetic neuralgia. Neurology. 1998, 50:1837-1841.
13. Watson CP, Moulin DE, Watt-Watson J, et al. Controlled release oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain. 2003, 105:71-78.
14. Gimbel JS, Richards P, Portenoy RK Controlled-release oxycodone for pain in diabetic neuropathy: A randomized controlled trial. Neurology. 2003, 60:927-934.
15. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009, 10:113-130. American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel.
16. Gourlay DL, Heit HA, Almahrezi A Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Med. 2005, 6:107-112.
17. Lewis JW Clinical pharmacology of buprenorphine in relation to its use as an analgesic. Buprenorphine: Combating Drug Abuse With a Unique Opioid 1995, 151-163. Wiley-Liss Inc, New York, NY. A. Cowan, J.W. Lewis (Eds.).
18. Russo MA, Wasiak J A clinical snapshot of transdermal buprenorphine in pain management. Eur J Pain Suppl. 2007, 1:74-77.
19. Pergolizzi J, Böger RH, Budd K, et al. Opioids and the management of chronic severe pain in the elderly: Consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization Step Ill opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract. 2008, 8:287-313.
20. Cowan A, Friderichs E, Strassburger W, Raffa RB Basic pharmacology of buprenorphine. Buprenorphine-the Unique Opioid Analgesic. Pharmacology and Clinical Application 2005, 3-21. Thieme Medical Publishing, New York, NY. K. Budd, R.B. Raffa (Eds.).
21. Sittl R Transdermal buprenorphine in clinical practice. Buprenorphine-the Unique Opioid Analgesic. Pharmacology and Clinical Application 2005, 92-101. Thieme Medical Publishing, New York, NY. K. Budd, R.B. Raffa (Eds.).
22. BuTrans (buprenorphine transdermal system) product monograph. Pickering, Ont: Purdue Pharma 2010.
23. Karlsson M, Berggren AC Efficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 microg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: A 12-week, randomized, open-label, controlled, parallel-group noninferiority study. Clin Ther. 2009, 31:503-513.
24. Landau CJ, Carr WD, Razzetti AJ, et al. Buprenorphine transdermal delivery system in adults with persistent noncancer-related pain syndromes who require opioid therapy: A multicenter, 5-week run-in and randomized, double-blind maintenance-of-analgesia study [published correction appears in Clin Ther. 2009;31:677]. Clin Ther. 2007, 29:2179-2193.
25. Gordon A, Rashiq S, Moulin D, et al. Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. Pain Res Manag. In press.
26. Dworkin RH, Turk DC, Farrar JT, for IMMPACT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005, 113:9-19.
27. Katchman AN, McGroary KA, Kilborn MJ, et al. Influence of opioid agonists on cardiac human ether-a-go-go related gene K(+) currents. J Pharmacol Exp Ther. 2002, 303:688-694.
28. Beaulieu AD, Peloso P, Bensen W, et al. A randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain. Clin Ther. 2007, 29:49-60.
29. Russell A, Watson CP, Clark AJ, et al. Evaluation of dosing guidelines for use of controlled-release codeine in chronic noncancer pain. Pain Res Manag. 2003, 8:143-148.
30. Hagen NA, Thirlwell M, Eisenhoffer J, et al. Efficacy, safety, and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain. J Pain Symptom Manage. 2005, 29:80-90.
31. Snyder-Halpern R, Verran JA Instrumentation to describe subjective sleep characteristics in healthy subjects. Res Nurs Health. 1987, 10:155-163.
32. Kosinski M, Janagap C, Gajria K, et al. Pain relief and pain-related sleep disturbance with extended-release tramadol in patients with osteoar-thritis. Curr Med Res Opin. 2007, 23:1615-1626.
33. Miaskowski C Pharmacologic management of sleep disturbances in noncancer-related pain. Pain Manag Nurs. 2009, 10:3-13.
34. Pollard CA Preliminary validity study of the pain disability index. Percept Mot Skills. 1984, 59:974.
35. Tait RC, Chibnall JT, Krause S The Pain Disability Index: Psychometric properties. Pain. 1990, 40:171-182.
36. Kopec JA, Esdaile JM, Abrahamo-wicz M, et al. The Quebec Back Pain Disability Scale. Measurement properties. Spine (Phila Pa 1976). 1995, 20:341-352.
37. Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: New outcome measure for primary care. BMJ. 1992, 305:160-164.
38. Bronfort G, Bouter LM Responsiveness of general health status in chronic low back pain: A comparison of the COOP Charts and the SF-36. Pain. 1999, 83:201-209.
39. Sibley J, Kelly A, Rashiq S, et al. Controlled release oxycodone and acetaminophen plus codeine in chronic low back pain. Presented at: 10th World Congress on Pain August 17-22, 2002, Abstract 429.
40. Handelsman L, Cochrane KJ, Aronson MJ, et al. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse. 1987, 13:293-308.
41. Elkader AK, Brands B, Callaghan R, Sproule BA Exploring the relationship between perceived inter-dose opioid withdrawal and patient characteristics in methadone maintenance treatment. Drug Alcohol Depend. 2009, 105:209-214.
42. Points to consider on multiplicity issues in clinical trials European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, Accessed January 8, 2010. http://www.emea.europa.eu/pdfs/human/ewp/090899en.pdf.
43. Jones B, Kenward MG Design and Analysis of Cross-Over Trials 2003, Chapman & Hall/ CRC, Boca Raton, Fla. 2nd ed.
44. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs: E14 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartate Guideline, Accessed March 23, 2010. http://www.ich.org/cache/compo/475-272-1.html#E14.
45. Thorne C, Beaulieu AD, Callaghan DJ, et al. A randomized, doubleblind, crossover comparison of the efficacy and safety of oral controlledrelease tramadol and placebo in patients with painful osteoarthritis. Pain Res Manag. 2008, 13:93-102.
46. Morin CM, Gibson D, Wade J Selfreported sleep and mood disturbance in chronic pain patients. Clin J Pain. 1998, 14:311-314.
47. Fanoe S, Hvidt C, Ege P, Jensen GB Syncope and QT prolongation among patients treated with methadone for heroin dependence in the city of Copenhagen. Heart. 2007, 93:1051-1055.
48. Wedam EF, Bigelow GE, Johnson RE, et al. QT-interval effects of metha-done, levomethadyl, and buprenor-phine in a randomized trial. Arch Intern Med. 2007, 167:2469-2475.
49. Duragesic (fentanyl transdermal system) product monograph. Toronto, Ont: Janssen-Ortho Inc 2009.