Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: A randomized, double-blind study

Current Medical Research and Opinion

Volumn 25, Issue 5, 2009, Pages 1095-1104

  Hale, Martin ^a   Upmalis, David ^b   Okamoto, Akiko ^b   Lange, Claudia ^c   Rauschkolb, Christine ^b  

^a Gold Coast Research   (United States)

^b JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^c GRÜNENTHAL GMBH   (Germany)

Author keywords

Analgesics; Low back pain; Mu opioid receptors; Osteoarthritis; Tapentadol

Indexed keywords

OXYCODONE; TAPENTADOL;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HIP OSTEOARTHRITIS; HUMAN; INCIDENCE; KNEE OSTEOARTHRITIS; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROLOGIC DISEASE; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SKIN DISEASE; SOMNOLENCE; TREATMENT DURATION; VOMITING; WITHDRAWAL SYNDROME; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANALGESICS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMPOUNDING; FEMALE; HUMANS; LOW BACK PAIN; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; OXYCODONE; PAIN; PHENOLS; TIME FACTORS; TREATMENT OUTCOME;

EID: 67649414317     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990902816970     Document Type: Article

References (34)

1. Bassols A, Bosch F, Banos JE. How does the general population treat their pain? A survey in Catalonia, Spain. J Pain Symptom Manage 2002;23:318-328 (Pubitemid 34462944)
2. Catala E, Reig E, Artes M, et al. Prevalence of pain in the Spanish population: telephone survey in 5000 homes. Eur J Pain 2002;6:133-140
3. Elliott AM, Smith BH, Penny KI, et al. The epidemiology of chronic pain in the community. Lancet 1999;354:1248-1252 (Pubitemid 29469353)
4. Eriksen J, Jensen MK, Sjogren P, et al. Epidemiology of chronic non-malignant pain in Denmark. Pain 2003;106:221-228 (Pubitemid 37505870)
5. Smith BH, Elliott AM, Chambers WA, et al. The impact of chronic pain in the community. Fam Pract 2001;18:292-299 (Pubitemid 32514684)
6. Stewart WF, Ricci JA, Chee E, et al. Lost productive work time costs from health conditions in the United States: results from the American Productivity Audit. J Occup Environ Med 2003;45:1234-1246 (Pubitemid 37541937)
7. Swegle JM, Logemann C. Management of common opioid-induced adverse effects. Am Fam Physician 2006;74:1347-1354 (Pubitemid 44607306)
8. Furlan AD, Sandoval JA, Mailis-Gagnon A, et al. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 2006;174:1589-1594 (Pubitemid 43829515)
9. Langford RM. Pain management today - what have we learned? Clin Rheumatol 2006;25(Suppl. 7):2-8
10. Andersohn F, Suissa S, Garbe E. Use of first- and second-generation cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs and risk of acute myocardial infarction. Circulation 2006;113:1950-1957 (Pubitemid 43754197)
11. Mattia C, Coluzzi F. COX-2 inhibitors: pharmacological data and adverse effects. Minerva Anestesiol 2005;71:461-470 (Pubitemid 43932972)
12. Avouac J, Gossec L, Dougados M. Efficacy and safety of opioids for osteoarthritis: a meta-analysis of randomized controlled trials. Osteoarthritis Cartilage 2007;15:957-965 (Pubitemid 47209257)
13. Kinkade S. Evaluation and treatment of acute low back pain. Am Fam Physician 2007;75:1181-1192 (Pubitemid 46631816)
14. VanDenKerkhof EG, Hopman WM, Towheed T, et al. Pain, health-related quality of life and health care utilization after inpatient surgery: a pilot study. Pain Res Manag 2006;11:41-47
15. Tzschentke TM, De Vry J, Terlinden R, et al. Tapentadol HCl. Drugs Future 2006;31:1053-1061
16. Tzschentke TM, Christoph T, Kögel B, et al. (-)-(1R,2R)-3-(3- Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): a novel μ-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther 2007;323:265-276 (Pubitemid 47443277)
17. 14C-labeled tapentadol HCl in healthy male subjects. Eur J Drug Metab Pharmacokinet 2007;32:163-169
18. Kleinert R, Lange C, Steup A, et al. Single dose analgesic efficacy of tapentadol in postsurgical dental pain: the results of a randomized, double-blind, placebo-controlled study. Anesth Analg 2008;107:2048-2055
19. Weber H, Hallman C, Steup A, et al. Efficacy and safety of tapentadol HCl in patients with pain after bunionectomy [abstract]. J Pain 2006;7(Suppl 1):S3
20. Mendoza TR, Chen C, Brugger A, et al. Lessons learned from a multiple-dose post-operative analgesic trial. Pain 2004;109:103-109 (Pubitemid 38479775)
21. Stegmann J-U, Weber H, Steup A, et al. The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery. Curr Med Res Opin 2008;24:3185-3196
22. Daniels SE, Upmalis D, Okamoto A, etal. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin 2009;25:765-776
23. Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs 2003;35:253-259 (Pubitemid 36927370)
24. Handelsman L, Cochrane KJ, Aronson MJ, et al. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse 1987;13:293-308 (Pubitemid 17143298)
25. International conference on harmonisation; guidance on statistical principles for clinical trials; availability - FDA. Notice. Fed Regist 1998;63:49583-49598
26. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med 1999;18:1905-1942
27. Peloso PM, Fortin L, Beaulieu A, et al. Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet®) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol 2004;31:2454-2463 (Pubitemid 39603097)
28. Webster LR, Butera PG, Moran LV, et al. Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 2006;7:937-946 (Pubitemid 44854737)
29. Kieffer BL. Opioids: first lessons from knockout mice. Trends Pharmacol Sci 1999;20:19-26 (Pubitemid 29304521)
30. Matthes HW, Maldonado R, Simonin F, et al. Loss of morphine-induced analgesia, reward effect and withdrawal symptoms in mice lacking the mu-opioid-receptor gene. Nature 1996;383:819-823 (Pubitemid 26372664)
31. Carter GT, Sullivan MD. Antidepressants in pain management. Curr Opin Investig Drugs 2002;3:454-458 (Pubitemid 34456067)
32. Ventafridda V, Bianchi M, Ripamonti C, et al. Studies on the effects of antidepressant drugs on the antinociceptive action of morphine and on plasma morphine in rat and man. Pain 1990;43:155-162 (Pubitemid 20385179)
33. 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. Ann Intern Med 2007;147:478-491 (Pubitemid 351688341)
34. McQuay H. Opioids in pain management. Lancet 1999;353:2229-2232 (Pubitemid 29295264)