Extent and time course of pain intensity upon treatment with a topical diclofenac sodium patch versus placebo in acute traumatic injury based on a validated end point: Post hoc analysis of a randomized placebo-controlled trial

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 4, 2010, Pages 493-498

  Mueller, Edgar A ^a   Kirch, Wilhelm ^a   Reiter, Susanne ^b  

^a DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^b Federal Institute for Drugs and Medical Devices   (Germany)

Author keywords

Acute traumatic injury; Clinical trials; Diclofenac; NSAIDs; Pain relief; Topical

Indexed keywords

DICLOFENAC; PLACEBO;

ADULT; ANALGESIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN; PAIN ASSESSMENT; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SOFT TISSUE INJURY; SPORT INJURY; TONOMETRY; VISUAL ANALOG SCALE;

ACUTE DISEASE; ADMINISTRATION, TOPICAL; ADOLESCENT; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ATHLETIC INJURIES; DICLOFENAC; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; TIME FACTORS; TREATMENT OUTCOME; WOUNDS, NONPENETRATING; YOUNG ADULT;

EID: 77249093201     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656560903535898     Document Type: Article

References (21)

1. Banning M. Topical diclofenac: clinical effectiveness and current uses in osteoarthritis of the knee and soft tissue injuries. Expert Opin Pharmacother 2008;9:2921-9
2. Zacher J, Altman R, Bellamy N, et al. Topical diclofenac and its role in pain and inflammation: an evidence-based review. Curr Med Res Opin 2008;24:925-50
3. Gallacchi G, Marcolongo R. Pharmacokinetics of diclofenac hydroxyethylpyrrolidine (DHEP) plasters in patients with monolateral knee joint effusion. Drugs Exp Clin Res 1993;19:95-7
4. Assandri A, Canali S, Giachetti C. Local tolerability and pharmacokinetic profile of a new transdermal delivery system, diclofenac hydroxyethylpyrrolidine plaster. Drugs Exp Clin Res 1993;19:89-95
5. Predel HG, Koll R, Pabst H, et al. Diclofenac patch for topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study. Br J Sports Med 2004;38:318-23 •• Pivotal study showing that diclofenac sodium patch is effective and safe for the treatment of blunt impact injuries.
6. Gschwend MH, Martin W, Arnold P, et al. Determination of the transdermal bioavailability of a newly developed diclofenac sodium patch in comparison with a reference preparation. Arzneimittelforschung 2005;55:403-13 • Study that characterizes the transdermal diclofenac bioavailability from diclofenac sodium patch.
7. Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis. CPMP/EWP/784/97 Rev 1, 23 April 2009 (Draft). Available from: http://www.emea. europa.eu/pdfs/human/ewp/078497endraft.pdf [Last accessed 28 September 2009]
8. Huskisson EC. Measurement of pain. Lancet 1974;2:1127-31
9. Huskisson EC. Measurement of pain. J Rheumatol 1982;9:768-9
10. Maurer W, Hothorn LA, Lehmacher W. Multiple comparisons in drug clinical trials and preclinical assays: a-priori ordered hypotheses. In: Vollmar J, editor, Biometrie in der chemisch-pharmazeutischen Industrie. Band 6. Stuttgart, Gustav Fischer Verlag; 1995. p. 3-18
11. Mason L, Moore RA, Edwards JE, et al. Topical NSAIDs for acute pain: a meta-analysis. BMC Fam Pract 2004;5:10 •• Meta-analysis of randomized, double-blind trials in patients with acute pain conditions.
12. Galer BS, Rowbotham M, Perander J, et al. Topical diclofenac patch relieves minor sports injury pain: results of a multicenter controlled clinical trial. J Pain Symptom Manage 2000;19:287-94
13. Schermer R. Topical therapy for sprains of the ankle joint. A double-blind study of the efficacy of diclofenac-diethylammonium in an emulsion-gel. Wehrmed Mschr 1991;9:415-17
14. Petersen B, Rovati S. Diclofenac epolamine (Flector®) patch: evidence for topical activity. Clin Drug Investig 2009;29:1-9
15. Rainsford KD, Kean WF, Ehrlich GE. Review of the pharmaceutical properties and clinical effects of the topical NSAID formulation, diclofenac epolamine. Curr Med Res Opin 2008;24:2967-92
16. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med 1998;5:1086-90
17. 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;27:2635-41 • Defines clinically relevant thresholds for pain improvement in patients with osteoarthritis.
18. Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 2005;64:29-33 • Defines clinically relevant thresholds for pain improvement in patients with osteoarthritis.
19. Bjordal JM, Klovning A, Ljunggren AE, et al. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: a meta-analysis of randomised placebo-controlled trials. Eur J Pain 2007;11:125-38 •• Meta-analysis of randomized, placebo-controlled trials in patients with osteoarthritic knee pain.
20. Moore RA, Moore OA, Derry S, et al. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis 2009: published online 12 April 2009, doi: 10.1136/ard.2009.107805
21. Heyneman CA. Topical nonsteroidal antiinflammatory drugs for acute soft tissue injuries. Ann Pharmacother 1995;29:780-2