A multicentre, randomized, 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 (United Kingdom)

Volumn 52, Issue 7, 2013, Pages 1303-1312

  Conaghan, Philip G ^a   Dickson, John ^b   Bolten, Wolfgang ^c   Cevc, Gregor ^d,e   Rother, Matthias ^d,f  

^a Chapel Allerton Hospital   (United Kingdom)

^b SOUTH TEES HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^c Rheumaklinik Wiesbaden   (Germany)

^d IDEA AG   (Germany)

^e Advanced Treatments Institute   (Germany)

^f Clinical Operations   (Germany)

Author keywords

IDEA 033; Ketoprofen; Osteoarthritis; TDT 064; Topical therapy; Transfersome

Indexed keywords

CELECOXIB; KETOPROFEN; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL LABORATORY; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; FEMALE; GASTROINTESTINAL SYMPTOM; GEL; HUMAN; JOINT STIFFNESS; KNEE OSTEOARTHRITIS; KNEE PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PHOSPHOLIPID VESICLE; PHYSICAL EXAMINATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RIGIDITY; RISK ASSESSMENT; SIDE EFFECT; TOPICAL TREATMENT; TREATMENT FAILURE; VITAL SIGN; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX;

IDEA-033; KETOPROFEN; OSTEOARTHRITIS; TDT 064; TOPICAL THERAPY; TRANSFERSOME;

ADMINISTRATION, ORAL; ADMINISTRATION, TOPICAL; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CYCLOOXYGENASE 2 INHIBITORS; DOUBLE-BLIND METHOD; DRUG CARRIERS; FEMALE; GELS; HUMANS; KETOPROFEN; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE; PAIN; PAIN MEASUREMENT; PYRAZOLES; SULFONAMIDES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84879822928     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ket133     Document Type: Article

References (33)

1. Altman RD. Early management of osteoarthritis. Am J Manag Care 2010;16:S41-7.
2. Conaghan PG, Dickson J, Grant RL. Guideline Development Group Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ 2008;336:502-3.
3. Jinks C, Jordan K, Croft P. Osteoarthritis as a public health problem: the impact of developing knee pain on physical function in adults living in the community: (KNEST 3). Rheumatology 2007;46:877-81.
4. Le TK, Montejano LB, Cao Z et al. Health care costs in US patients with and without a diagnosis of osteoarthritis. J Pain Res 2012;5:23-30.
5. Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int 2012;32: 1491-502.
6. Harirforoosh S, Jamali F. Renal adverse effects of nonsteroidal anti-inflammatory drugs. Expert Opin Drug Saf 2009;8:669-81.
7. Laine L, Smith R, Min K et al. Systematic review: the lower gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2006;24: 751-67.
8. Chan FK, Abraham NS, Scheiman JM et al. Management of patients on nonsteroidal anti-inflammatory drugs: a clinical practice recommendation from the First International Working Party on Gastrointestinal and Cardiovascular Effects of Nonsteroidal Anti-inflammatory Drugs and Anti-platelet Agents. Am J Gastroenterol 2008; 103:2908-18.
9. Lanas A, Garcia-Tell G, Armada B et al. Prescription patterns and appropriateness of NSAID therapy according to gastrointestinal risk and cardiovascular history in patients with diagnoses of osteoarthritis. BMC Med 2011; 9:38.
10. Lin J, Zhang W, Jones A et al. Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials. BMJ 2004;329:324.
11. Zhang W, Nuki G, Moskowitz RW et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18:476-99.
12. Cevc G, Vierl U. Nanotechnology and the transdermal route. A state of the art review and critical appraisal. J Control Release 2010;141:277-99.
13. Cevc G, Mazgareanu S, Rother M. Preclinical characterisation of NSAIDs in ultradeformable carriers or conventional topical gels. Int J Pharm 2008;360:29-39.
14. Dominicus R, Weidner C, Tate H et al. Open-label study of the efficacy and safety of topical treatment with TDT 067 (terbinafine in Transfersome-) in patients with onychomycosis. Br J Dermatol 2012;166:1360-2.
15. Kneer W, Rother I, Rother M et al.; 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.
16. Rother M, Lavins BJ, Kneer W et al. 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.
17. Stucki G, Rother M; 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 (Abstract). Ann Rheum Dis 2007; 66(Suppl II):S510.
18. Rabeneck L, Cook KF, Wristers K et al. SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001;54: 755-65.
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. Rother M, Lipetz R, Dunmyer S. A double-blind, randomised, placebo-controlled trial to evaluate the safety and efficacy of epicutaneously applied ketoprofen in Transfersome gel for the treatment of pain associated with osteoarthritis (OA) of the knee (Abstract). Annual EULAR Congress 2012. Abstract no. EULAR12-3378.
21. McKenna F, Borenstein D, Wendt H et al. Celecoxib versus diclofenac in the management of osteoarthritis of the knee. Scand J Rheumatol 2001;30:11-8
22. Bensen WG, Fiechtner JJ, McMillen JI et al. Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial. Mayo Clin Proc 1999;74:1095-105.
23. Moskowitz RW, Sunshine A, Brugger A et al. American pain society pain questionnaire and other pain measures in the assessment of osteoarthritis pain: a pooled analysis of three celecoxib pivotal studies. Am J Ther 2003;10: 12-20.
24. Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (Pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med 2004;164: 2017-23.
25. Simon LS, Grierson LM, Naseer Z et al. Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. Pain 2009;143: 238-45.
26. Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (Pennsaid-) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol 2004;31:2002-12.
27. Farrar JT, Young JP Jr, 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.
28. Hannan MT, Felson DT, Pincus T. Analysis of the discordance between radiographic changes and knee pain in osteoarthritis of the knee. J Rheumatol 2000;27: 1513-7.
29. Zhang W, Robertson J, Jones AC et al. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2008;67: 1716-23.
30. Ondarza A, Lewis F, Womack T. Placebo effect of transdermal NSAIDS: the implications and challenges of the placebo effect on regulatory agency product approval. Applied Clinical Trials Online. June 2011. www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Trial+Design+Articles/Placebo-Effect-of-Transdermal-NSAIDS/ArticleStandard/Article/detail/726497 (16 November 2012, date last accessed).
31. Rother M, Vester JC, Bolten W et al. Meta-analysis of four 12-week phase III clinical trials investigating the effect of TDT 064, a transdermal gel, in osteoarthritis of the knee (Abstract). American College of Rheumatology/ Association of Rheumatology Healthcare Professionals Annual Meeting 2012b. Abstract no. 257.
32. Lai KC, Chu KM, Hui WM et al. Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications. Am J Med 2005;118:1271-8.
33. Heyneman CA, Lawless-Liday C, Wall GC. Oral versus topical NSAIDs in rheumatic diseases. Drug 2000;60: 555-74.