Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis

Clinical Therapeutics

Volumn 28, Issue 2, 2006, Pages 222-235

  Temple, Anthony R ^a   Benson, Gordon D ^b   Zinsenheim, Joyce R ^c   Schweinle, Jo Ellen ^d  

^a McNeil Laboratories Inc   (United States)

^b RUTGERS ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^c YZMA Consultants   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

acetaminophen, analgesics, non narcotic, osteoarthritis, pain, tolerability

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; HEMOGLOBIN; NAPROXEN; PARACETAMOL; ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT;

ABDOMINAL PAIN; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CLINICAL EXAMINATION; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ENZYME ACTIVITY; ERUCTATION; FEMALE; FLATULENCE; FOLLOW UP; GASTRITIS; GASTROINTESTINAL HEMORRHAGE; HIP OSTEOARTHRITIS; HUMAN; INSOMNIA; KIDNEY FAILURE; KIDNEY FUNCTION; KNEE OSTEOARTHRITIS; KNEE PAIN; LIVER DYSFUNCTION; LIVER FAILURE; LIVER FUNCTION; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MELENA; MULTICENTER STUDY; NAUSEA; NEPHRITIS; OSTEOARTHRITIS; PAIN ASSESSMENT; PERIPHERAL EDEMA; PHYSICAL EXAMINATION; PHYSICIAN; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; RIGIDITY; SOMNOLENCE; STATISTICAL SIGNIFICANCE; TINNITUS; TREATMENT DURATION; VISUAL ANALOG SCALE; XEROSTOMIA; DRUG ADMINISTRATION; MIDDLE AGED; PATIENT COMPLIANCE; TREATMENT OUTCOME;

ACETAMINOPHEN; ADULT; AGED; ANALGESICS, NON-NARCOTIC; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; NAPROXEN; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PATIENT COMPLIANCE; TREATMENT OUTCOME;

EID: 33744737506     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.02.004     Document Type: Article

References (25)

1. Kaufman D., Kelly J., Rosenberg L., et al. Recent patterns of medication use in the ambulatory adult population of the United States: The Slone Survey. JAMA 287 (2002) 337-344
2. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 Update. Arthritis Rheum 43 (2000) 1905-1915
3. Simon L., Lipman A., Caudill-Slosberg M., et al. Guideline for the Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Chronic Arthritis. 2nd ed. (2002), American Pain Society, Glenview, Ill
4. Jordan K., Arden N., Doherty M., et al., for the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). EULAR Recommendations 2003: An evidence based approach to the management of knee osteoarthritis: Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 62 (2003) 1145-1155
5. Zhang W., Doherty M., Arden N., et al., for the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 64 (2005) 669-681
6. Hochberg M., Altman R., Brandt K., et al., for the American College of Rheumatology. Guidelines for the medical management of osteoarthritis. Part I. Osteoarthritis of the hip. Arthritis Rheum. 38 (1995) 1535-1540
7. Amadio Jr. P., and Cummings D. Evaluation of acetaminophen in the management of osteoarthritis of the knee. Curr Ther Res Clin Exp. 34 (1983) 59-66
8. Bradley J., Brandt K., Katz B., et al. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 325 (1991) 87-91
9. Pincus T., Koch G., Sokka T., et al. A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee. Arthritis Rheum. 44 (2001) 1587-1598
10. for the Vioxx, Acetaminophen, Celecoxib Trial (VACT) Group. Geba G., Weaver A., Polis A., et al. Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: A randomized trial. [published correction appears in JAMA. 2002; 287:989]. JAMA 287 (2002) 64-71
11. Chicago, Ill. Abstract P327, Available at. Altman R., Schweinle J., Zinsenheim J., and Temple A. Three-month efficacy and safety of acetaminophen for osteoarthritis pain of the hip or knee. Accessed January 24, 2005. Presented at the OsteoArthritis Research Society International (OARSI) 9th World Congress (December 2-5, 2004). http://www.oarsi.org/04Abstracts/Final_OARSI04_Abstracts.pdf
12. Williams H., Ward J., Egger M., et al. Comparison of naproxen and acetaminophen in a two-year study of treatment of osteoarthritis of the knee. Arthritis Rheum. 36 (1993) 1196-1206
13. Dippel D., van Breda E., van Gemert H., et al. Effect of paracetamol (acetaminophen) on body temperature in acute ischemic stroke: A double-blind, randomized phase II clinical trial. Stroke. 32 (2001) 1607-1612
14. Dippel D., van Breda E., van der Worp H., et al., for the PISA-Investigators. Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]. BMC Cardiovasc Disord. 3 (2003) 2
15. Poster PII-104. Gelotte C., Auiler J., Lynch J., et al. Metabolite patterns measured during repeated dosing of acetaminophen (acetaminophen) at 4, 6, and 8 g/day in healthy adults. Poster presented at: American Society for Clinical Pharmacology and Therapeutics 105th Annual Meeting. Miami Beach, Fla. (March 24-27, 2004)
16. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. Cardiovasc Res. 35 (1997) 2-3
17. Altman R., Asch E., Bloch D., et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 29 (1986) 1039-1049
18. Hochberg M., Altman R., Brandt K., et al., for the American College of Rheumatology. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. Arthritis Rheum. 38 (1995) 1541-1546
19. Kellgren J., and Lawrence J. Radiological assessment of osteoarthrosis. Ann Rheum Dis. 16 (1957) 494-502
20. Sobell L., and Sobell M. Alcohol Timeline Followback Users' Manual (1995), Addiction Research Foundation, Toronto, Can
21. Merz M., Seiberling M., Hoxter G., et al. Elevation of liver enzymes in multiple dose trials during placebo treatment: Are they predictable?. J Clin Pharmacol. 37 (1997) 791-798
22. Rosenzweig P., Miget N., and Brohier S. Transaminase elevation on placebo during phase I trials: Prevalence and significance. Br J Clin Pharmacol. 48 (1999) 19-23
23. Senior J. Insights into the pathogenesis and treatment of toxin-induced liver disease. Oral presentation at: North American Congress of Clinical Toxicology. Seattle, Wash. (September 10, 2004)
24. Available at. Clinical study report: Acetaminophen caplet ER 650 mg. McNeil Consumer & Specialty Pharmaceuticals. 1. Synopsis. A randomized, double-blind, placebo-controlled study evaluating acetaminophen extended release (3900 mg/day) in the treatment of osteoarthritis of the hip or knee. Accessed November 2005. http://download.veritasmedicine.com/PDF/CR002488_CSR.pdf
25. Available at. Clinical study report: Acetaminophen caplet ER 650 mg. McNeil Consumer & Specialty Pharmaceuticals. 1. Synopsis. A randomized, double-blind, placebo-controlled study evaluating acetaminophen extended release (1950 mg/day and 3900 mg/day) in the treatment of osteoarthritis of the hip or knee. Accessed November 2005. http://download.veritasmedicine.com/PDF/CR002485_CSR.pdf