Treatment of chronic moderate-to-severe non-malignant pain with polymer-coated extended-release morphine sulfate capsules

Current Medical Research and Opinion

Volumn 22, Issue 3, 2006, Pages 539-550

  Nicholson, Bruce ^a   Ross, Edgar ^b   Weil, Arnold ^c   Sasaki, John ^d   Sacks, Gerald ^e  

^a Pain Specialists of Greater Lehigh Valley   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c Non Surgical Orthopaedic and Spine Center   (United States)

^d Casa Colina Centers for Rehabilitation   (United States)

^e SAINT JOHN'S HEALTH CENTER   (United States)

Author keywords

Chronic pain; KADIAN; Long term analgesia; Morphine; Non malignant pain; Opioid

Indexed keywords

MORPHINE SULFATE; POLYMER;

ADULT; ARTICLE; CHRONIC PAIN; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DISEASE SEVERITY; DIZZINESS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG RELEASE; DRUG TOLERABILITY; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTPATIENT DEPARTMENT; PATIENT SATISFACTION; PHASE 4 CLINICAL TRIAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; SEDATION; SHORT FORM 36; SIDE EFFECT; SLEEP; SOMNOLENCE; VOMITING; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; CAPSULES; CHI-SQUARE DISTRIBUTION; CHRONIC DISEASE; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; MORPHINE; PAIN; PAIN MEASUREMENT; POLYMERS; QUALITY OF LIFE; SLEEP; STATISTICS, NONPARAMETRIC; TREATMENT OUTCOME;

EID: 33645220346     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X89784     Document Type: Article

References (53)

1. American Pain Society. Pain: current understanding of assessment, management and treatments. 2004. Available from: http://www.ampainsoc.org/ce/ npc/I/a_introduction.htm [accessed 26 June 2005]
2. Nagda J, Bajwa ZH. Definitions and classification of pain. In: Warfield CA, Bajwa ZH, editors. Principles and practice of pain medicine. New York: McGraw-Hill; 2004. p. 52
3. Becker N, Bondegaard Thomsen A, Olsen AK, et al. Pain epidemiology and health related quality of life in chronic non-malignant pain patients referred to a Danish multidisciplinary pain center. Pain 1997;73:393-400
4. Roper Starch Worldwide Inc. Chronic pain in America: roadblocks to relief; 1999
5. Portenoy RK. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage 1996;11:203-17
6. Ballantyne JC, Mao J. Opioid therapy for chronic pain. New Engl J Med 2003;349:1943-53
7. McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 2001;8:181-6
8. Nicholson B. Responsible prescribing of opioids for the management of chronic pain. Drugs 2003;63:17-32
9. AGS Panel on Persistent Pain in Older Persons. The management of persistent pain in older persons. J Am Geriatr Soc 2002;50:(6 Suppl):S205-S224
10. Marcus DA. Treatment of nonmalignant chronic pain. Am Fam Physician 2000;61:1331-46
11. American Society of Anesthesiologists I. Practice guidelines for chronic pain management: a report by the American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section. Anesthesiology 1997;86:995-1004
12. Hale ME, Dvergsten C, Gimbel J. Efficacy and safety of oxymorphone extended release in chronic low back pain: results of a randomized, double-blind, placebo- and active-controlled phase III study. J Pain 2005;6:21-8
13. 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;160:853-60
14. Caldwell JR, Rapoport RJ, Davis JC, et al. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage 2002;23:278-91
15. Mahowald ML, Singh JA, Majeski P. Opioid use by patients in an orthopedics spine clinic. Arthritis Rheum 2005;52:312-21
16. Ytterberg SR, Mahowald ML, Woods SR. Codeine and oxycodone use in patients with chronic rheumatic disease pain. Arthritis Rheum 1998;41:1603-12
17. Watson CP, Babul N. Efficacy of oxycodone in neuropathic pain: a randomized trial in postherpetic neuralgia. Neurology 1998;50:1837-41
18. Rowbotham MC, Twilling L, Davies PS, et al. Oral opioid therapy for chronic peripheral and central neuropathic pain. New Engl J Med 2003;348:1223-32
19. Morley JS, Bridson J, Nash TP, et al. Low-dose methadone has an analgesic effect in neuropathic pain: a double-blind randomized controlled crossover trial. Palliat Med 2003;17:576-87
20. Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology 2003;60:927-34
21. Cherny NI, Thaler HT, Friedlander-Klar H, et al. Opioid responsiveness of cancer pain syndromes caused by neuropathic or nociceptive mechanisms: a combined analysis of controlled, single-dose studies. Neurology 1994;44:857-61
22. Jadad AR, Carroll D, Glynn CJ, et al. Morphine responsiveness of chronic pain: double-blind randomised crossover study with patient-controlled analgesia. Lancet 1992;339:1367-71
23. Dickinson BD, Altman RD, Nielsen NH, Williams MA. Use of opioids to treat chronic, noncancer pain. West J Med 2000;172:107-15
24. Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Blood Press 1992;1:113-9
25. Gourlay GK, Cherry DA, Onley MM, et al. Pharmacokinetics and pharmacodynamics of twenty-four-hourly Kapanol compared to twelve-hourly MS Contin in the treatment of severe cancer pain. Pain 1997;69:295-302
26. Broomhead A, Kerr R, Tester W, et al. Comparison of a once-a-day sustained-release morphine formulation with standard oral morphine treatment for cancer pain. J Pain Symptom Manage 1997;14:63-73
27. Broomhead A, West R, Kadirgamanathan G, et al. Comparative bioavailability of sustained-release morphine sulfate capsules versus pellets. Clin Drug Invest 1997;14:137-45
28. Maccarrone C, West RJ, Broomhead AF, Hodsman GP. Single dose pharmacokinetics of Kapanol™, a new oral sustained-release morphine formulation. Drug Invest 1994;7:262-74
29. Farrar JT, Young Jr JP, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11 -point numerical pain rating scale. Pain 2001;94:149-58
30. International Conference on Harmonisation. Guidance for industry. Good clinical practice: consolidated guidance (ICH-E6). Center for Drug Evaluation and Research (CDER), Rockville, MD
31. US Food and Drug Administration. Code of Federal Regulations, Title 21; 2004
32. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000, pp. 1-5
33. Ware Jr JE, Kosinski M, Dewey JE. How to score version 2 of the SF-36® Health Survey. Lincoln (RI): QualityMetric Incorporated; 2000
34. Nicholson B, Verma S. Comorbidities in chronic neuropathic pain. Pain Med 2004;5(Suppl 1):S9-S27
35. McCracken LM, Iverson GL. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manage 2002;7:75-9
36. Haythornthwaite JA, Hegel MT, Kerns RD. Development of a sleep diary for chronic pain patients. J Pain Symptom Manage 1991;6:65-72
37. Smith MT, Perlis ML, Smith MS, et al. Sleep quality and presleep arousal in chronic pain. J Behav Med 2000;23:1-13
38. Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. Br Med J 2002;324:1417
39. Ware Jr JE, Keller SD, Gandek B, et al. Evaluating translations of health status questionnaires. Methods from the IQOLA project. International Quality of Life Assessment. Int J Technol Assess Health Care 1995;11:525-51
40. McHorney CA, Ware Jr JE, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993;31:247-63
41. Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Br Med J 1992;305:160-4
42. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-92
43. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001;45:384-91
44. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004;110:628-38
45. KADIAN [package insert]. Piscataway (NJ): Alpharma Branded Products Division; 2004
46. Adams D, Gunyea I, Bhakta B, et al. Retrospective assessment of frequency of dosing of sustained release opiate preparations in chronic pain patients [abstract]. Pain Med 2002;3:185
47. McCaffery M, Pasero C. Breakthrough pain. Am J Nurs 2003;103:83-4, 86
48. Ackerman SJ, Mordin M, Reblando J, et al. Patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride controlled-release among patients with chronic nonmalignant pain. J Manag Care Pharm 2003;9:223-31
49. Mercadante S. Opioid rotation for cancer pain: rationale and clinical aspects. Cancer 1999;86:1856-66
50. Nicholson B, Weil A, Ross E, Sasaki J. Long-term effects of extended-release morphine sulfate (KADIAN®) vs controlled-release oxycodone HCl (OxyContin®) on relief of moderate to severe pain. Poster presented at: 66th Annual Assembly of the American Academy of Physical Medicine and Rehabilitation; October 27-30, 2005; Philadelphia (PA)
51. Unruh AM. Gender variations in clinical pain experience. Pain 1996;65:123-67
52. Marcus DA. Gender differences in chronic pain in a treatment-seeking population. J Gend Specif Med 2003;6:19-24
53. Swartzman LC, Burkell J. Expectations and the placebo effect in clinical drug trials: why we should not turn a blind eye to unblinding, and other cautionary notes. Clin Pharmacol Ther 1998;64:1-7