A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel

Journal of Rheumatology

Volumn 40, Issue 10, 2013, Pages 1742-1748

  Rother, Matthias ^a   Conaghan, Philip G ^b  

^a International Medical Research Partner GmbH   (Germany)

^b UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

Knee; Nonsteroidal antiinflammatory drugs; Osteoarthritis; Pain topical

Indexed keywords

KETOPROFEN;

ADULT; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRY SKIN; ERYTHEMA; FEMALE; GEL; HUMAN; KNEE OSTEOARTHRITIS; KNEE PAIN; MAJOR CLINICAL STUDY; MALE; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; SIDE EFFECT; SKIN IRRITATION; ULTRADEFORMABLE VESICLE GEL;

KNEE; NONSTEROIDAL ANTIINFLAMMATORY DRUGS; OSTEOARTHRITIS; PAIN; TOPICAL;

ADMINISTRATION, CUTANEOUS; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; KETOPROFEN; KNEE JOINT; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE; PAIN; TREATMENT OUTCOME;

EID: 84885125070     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.130192     Document Type: Article

References (23)

1. Dominick KL, Ahern FM, Gold CH, Heller DA. Health-related quality of life among older adults with arthritis. Health Qual Life Outcomes 2004;2:5.
2. Abell JE, Hootman JM, Zack MM, Moriarty D, Helmick CG. Physical activity and health related quality of life among people with arthritis. J Epidemiol Community Health 2005;59:380-5.
3. National Institute for Health and Clinical Excellence. Osteoarthritis: national clinical guideline for care and management in adults. London. 2008. [Internet. Accessed July 15, 2013.] Available from: www.nice.org.uk/CG059
4. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Org 2003;81:646-56.
5. Hawkeswood J, Reebye R. Evidence-based guidelines for the nonpharmacological treatment of osteoarthritis of the hip and knee. BCMJ 2010;52:399-403.
6. Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res 2012;64:455-74.
7. Al-Saeed A. Gastrointestinal and cardiovascular risk of nonsteroidal anti-inflammatory drugs. Oman Med J 2011;26:385-91.
8. Harirforoosh S, Jamali F. Renal adverse effects of nonsteroidal anti-inflammatory drugs. Expert Opin Drug Saf 2009;8:669-81.
9. Hernández-Díaz S, Varas-Lorenzo C, García Rodríguez LA. Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol 2006;98:266-74.
10. Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int 2012;32:1491-502.
11. Argoff CE, Gloth FM. Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients. Ther Clin Risk Manag 2011;7:393-9.
12. Barkin RL. Topical nonsteroidal anti-inflammatory drugs: the importance of drug, delivery, and therapeutic outcome. Am J Ther 2012 Feb. 22 [E-pub ahead of print].
13. Rother M, Lavins BJ, Kneer W, Lehnhardt K, Seidel EJ, Mazgareanu S. Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial. Ann Rheum Dis 2007;66:1178-83.
14. Stucki G, Rother M, for the European IDEA-033 Study Group. Randomized, double-blind, placebo-controlled study of three dosages of epicutaneously applied IDEA-033 (ketoprofen in Transfersome) in patients with osteoarthritis of the knee. Ann Rheum Dis 2007;66 Suppl II: 510.
15. Rother M, Yeoman G, Ekman E. A double-blind, placebo-controlled trial comparing the safety and efficacy of epicutaneously applied ketoprofen in Transfersome gel with naproxen for the treatment of pain associated with osteoarthritis (OA) of the knee. Ann Rheum Dis 2012;71 Suppl 3:583.
16. Kneer W, Rother I, Rother M, Seidel E; IDEA-033-III-01 Study Group. A multiple-dose, open-label, safety, compliance, and usage evaluation study of epicutaneously applied Diractin (ketoprofen in Transfersome) in joint/musculoskeletal pain or soft tissue inflammation. Curr Drug Saf 2009;4:5-10.
17. Conaghan P, Dickson JD, Bolten W, Cevc G, Rother M. A multicentre, randomised, placebo-and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology 2013 Mar. 28 [E-pub ahead of print].
18. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113:9-19.
19. Colditz GA, Miller JN, Mosteller F. Measuring gain in the evaluation of medical technology. The probability of a better outcome. Int J Technol Assess Health Care 1988;4:637-42.
20. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2008;67:1716-23.
21. Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (Pennsaid) in the treatment of primary osteoarthritis of the knee. Arch Intern Med 2004;164:2017-23.
22. Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ 2004;171:333-8.
23. Rother M, Vester JC, Bolten WW, Conaghan PG. Meta-analysis of four 12-week phase III clinical trials investigating the effect of TDT 064, a transdermal gel, in osteoarthritis of the knee. Arthritis Rheum 2012;64 Suppl 10; S111.