Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial

Clinical Journal of Pain

Volumn 21, Issue 6, 2005, Pages 524-535

  Markenson, Joseph A ^a   Croft, Joseph ^b   Zhang, P G ^c   Richards, Patricia ^c,d  

^a HOSPITAL FOR SPECIAL SURGERY   (United States)

^b Arthritis Center   (United States)

^c PURDUE PHARMA L P   (United States)

^d NONE   (United States)

Author keywords

Controlled release oxycodone; Osteoarthritis; Pain; Randomized clinical trial

Indexed keywords

NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; OXYCODONE; PARACETAMOL; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DISEASE ACTIVITY; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPHAGIA; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MOOD; NAUSEA; OSTEOARTHRITIS; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; SLEEP; SOMNOLENCE; STATISTICAL SIGNIFICANCE; SWEATING; TREATMENT OUTCOME; VOMITING; WALKING; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX SCORE;

AGED; AGED, 80 AND OVER; COHORT STUDIES; DEMOGRAPHY; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; MALE; MIDDLE AGED; NARCOTICS; OSTEOARTHRITIS; OXYCODONE; PAIN; PAIN MEASUREMENT; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT SATISFACTION; RETROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME;

EID: 27344432039     PISSN: 07498047     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ajp.0000146215.86038.38     Document Type: Article

References (41)

1. Silman AJ, Hochberg MC. Osteoarthritis. In: Silman AJ, Hochberg MC, eds. Epidemiology of the Rheumatic Diseases. Oxford: Oxford University Press; 1993:257-288.
2. CDC. Arthritis prevalence and activity limitations - United States, 1990. MMWR Morb Mortal Wkly Report. 1994;43:433-438.
3. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998;41:778-799.
4. Creamer P, Lethbridge-Cejku M, Hochberg MC. Where does it hurt? Pain localization in osteoarthritis of the knee. Osteoarthritis Cartilage. 1998;6: 318-323.
5. Peloso PM. Opioid therapy for osteoarthritis of the hip and knee: use it or lose it? J Rheumatol. 2001;28:6-11.
6. Creamer P, Hochberg MC. Why does osteoarthritis of the knee hurt - sometimes? Br J Rheumatol. 1995;36:726-728.
7. Stein C, Pflüger M, Yassouridis A, et al. No tolerance to peripheral morphine analgesia in presence of opioid expression in inflamed synovia. J Clin Invest. 1996;98:793-799.
8. Jordan J, Luta G, Renner J, et al. Knee pain and knee osteoarthritis severity in self-reported task-specific disability: the Johnston County Osteoarthritis Project. J Rheumatol. 1997;24:1344-1349.
9. Creamer P, Lethbridge-Cejku M, Hochberg MC. Factors associated with functional impairment in symptomatic knee osteoarthritis. Rheumatology (Oxford). 2000;39:490-496.
10. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43:1905-1915.
11. Wollheim FA. Current pharmacological treatment of osteoarthritis. Drugs. 1996;52(suppl 3):27-38.
12. Beaver WT. Impact of non-narcotic oral analgesics on pain management. Am J Med. 1988;84(suppl 5A):3-15.
13. Blantz RC. Acetaminophen: acute and chronic effects on renal function. Am J Kidney Dis. 1996;28(suppl 1):S3-S6.
14. Salgia ADT, Kosnik SD. When acetaminophen use becomes toxic: treating acute accidental and intentional overdose. Postgrad Med. 1999;105:81-90.
15. Carson JL, Willett LR. Toxicity of nonsteroidal anti-inflammatory drugs: an overview of the epidemiological evidence. Drugs. 1993;46(suppl 1): 243-248.
16. Smalley WE, Ray WA, Daugherty JR, et al. Nonsteroidal anti-inflammatory drugs and the incidence of hospitalizations for peptic ulcer disease in elderly persons. Am J Epidemiol. 1995;141:539-545.
17. Johnson AG, Seidemann P, Day RO. NSAID-related adverse drug interactions with clinical relevance: an update. Int J Clin Pharmacol Ther. 1994;32:509-532.
18. Kirchner JT. Nonsteroidal anti-inflammatory drug use in the elderly: issues of compliance and safety. J Am Osteopath Assoc. 1994;94:300-304.
19. Creamer P, Flores R, Hochberg MC. Management of osteoarthritis in older adults. Clin Geriatr Med. 1998;14:435-454.
20. Hersh EV, Moore PA, Ross GL. Over-the-counter analgesics and antipyretics: a critical assessment. Clin Ther. 2000;22:500-548.
21. Case JP, Baliunas AJ, Block JA. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis. Arch Intern Med. 2003;163: 169-178.
22. 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 anti-inflammatory drugs: a double blind, randomized, multicenter, placebo controlled trial. J Rheumatol. 1999;26:862-869.
23. Peloso PM, Bellamy N, Bensen 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.
24. 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.
25. The use of opioids for the treatment of chronic pain: a consensus statement from the American Academy of Pain Medicine and the American Pain Society. Clin J Pain. 1997;13:6-8.
26. American Pain Society. Guideline for the Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Chronic Arthritis. Glenview, IL: American Pain Society; 2002.
27. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Guidelines for the initial evaluation of the adult patient with acute musculoskeletal symptoms. Arthritis Rheum. 1996;39:1-8.
28. Turk D, Dworkin RH, Allen RR, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003;106:337-345.
29. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129-138.
30. Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833-1840.
31. McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Care Res. 2001;45:453-461.
32. Wolfe F. Determinants of WOMAC function, pain and stiffness scores: evidence for the role of low back pain, symptom counts, fatigue and depression in osteoarthritis, rheumatoid arthritis and fibromyalgia. Rheumatology (Oxford). 1999;38:355-361.
33. Domsic RT, Saltzman CL. Ankle osteoarthritis scale. Foot Ankle Int. 1998;19:466-471.
34. McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Care Res. 2001;45:453-461.
35. Ruta DA, Garratt AM, Leng M, et al. A new approach to the measurement of quality of life: the Patient-Generated Index. Med Care. 1994;32:1109-1126.
36. US Food and Drug Administration, Center for Drug Evaluation and Research. Coding Symbols for Thesaurus of Adverse Reaction Terms. 5th ed. Rockville, MD: US Food and Drug Administration.
37. Ehrich EW, Davies GM, Watson DJ, et al. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27:2635-2641.
38. Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized, clinical trial of osteoarthritis patients. Arthritis Care Res. 1999;12:172-179.
39. Yocum D, Fleischmann R, Dalgin P, et al, for the Meloxicam Arthritis Investigators. Safety and efficacy of meloxicam in the treatment of osteoarthritis: a 12-week, double-blind, multiple-dose, placebo-controlled trial. Arch Intern Med. 2000;160:2947-2954.
40. Hoffman DL, Friedman M, Colucci S, et al. Validation of the Brief Pain Inventory for patients with osteoarthritis [abstract]. J Pain. 2002;3(suppl 1):3.
41. OxyContin® (package insert). Stamford, CT: Purdue Pharma, L.P.; 2002.