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Efficacy of Topical Diclofenac Diethylamine Gel in Osteoarthritis of the Knee
FRITZ U. NIETHARD, MORRIS S. GOLD, GAIL S. SOLOMON, JIUN-MIN LIU, MARKUS UNKAUF, HELMUT H. ALBRECHT, and FRANCOIS ELKIK
ABSTRACT. Methods. Patients with OA of the knee washed out their OA medications for at least 5 drug half-lives. Patients with adequately high baseline pain scores were randomized to apply either double-blind active or placebo gel for 3 weeks. Acetaminophen (up to 2 g/day) was supplied as rescue medication. In a diary, patients recorded compliance to dosing and use of rescue medication and assessed daily pain on movement, spontaneous pain, and pain relief. At weekly site visits, patients completed the Western Ontario and McMaster (WOMAC) Osteoarthritis Index Questionnaire, which includes assessment of pain, stiffness, and physical function, and assessed pain intensity "right now." At the final visit, a global assessment of treatment efficacy was completed. Results. Of 238 randomized patients, 237 were included in the intent to treat efficacy analysis. Treatments differed significantly for daily pain on movement at Day 5, and continued on most days through end of study. Peak differences were achieved in the second week. On the primary outcome, average pain on movement over Days 1–14, diclofenac gel was significantly superior to placebo gel. Scores for all 3 WOMAC indices for diclofenac gel treatment were significantly superior to placebo at Weeks 2 and 3. A significant difference was achieved on pain intensity "right now" at all 3 weeks. At the end of the study, patients rated diclofenac gel as significantly more effective in treating the pain of OA of the knee (p = 0.03) compared to placebo. There were no safety issues concerning adverse events or laboratory values. Conclusion. Diclofenac gel was effective and safe for relief of symptoms of OA of the knee over 3 weeks of dosing. (J Rheumatol 2005;32:2384-92) Key Indexing Terms:
DICLOFENAC
From the Orthopaedic Clinic, Universitätsklinikum Aachen, Aachen; Novartis Consumer Health, Parsippany, New Jersey, USA; and Novartis Consumer Health, Munich, Germany. Supported by Novartis Consumer Health. F.U. Niethard, MD, Director, Orthopaedic Clinic, Universitätsklinikum Aachen; M.S. Gold, ScD, Director, Biostatistics and Data Management; G.S. Solomon, MS, Principal Scientist; J.H. Liu, MS, Principal Scientist, Biostatistics; H.H. Albrecht, MD, MS, FFPM, Vice-President, Pre-Clinical and Clinical Development and Drug Safety; F.E. Elkik, MD, Head, Clinical Research, Novartis Consumer Health, Parsippany, NJ; M. Unkauf, VMD Director, Regulatory and Medical Affairs, Novartis Consumer Health, Munich, Germany. F.U. Niethard was the principal investigator of the study. Address reprint requests to Dr. M. Unkauf, Novartis Consumer Health, Zielstattstrasse 40, D-81379 Munich, Germany. E-mail: markus.unkauf@ch.novartis.com Accepted for publication July 25, 2005. |