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Rheumatology 2002; 41: 1052-1061
© 2002 British Society for Rheumatology

Original papers

Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis

K. Gottesdiener, T. Schnitzer1, C. Fisher2, B. Bockow3, J. Markenson4, A. Ko5, L. DeTora6,, S. Curtis6, L. Geissler, B. J. Gertz and for the Protocol 007 Study Group

Clinical Pharmacology, Merck Research Laboratories, Rahway, NJ,
1 Department of Medicine, Northwestern University Medical School, Chicago, IL,
2 Health Research of Hampton Roads, Newport News, VA,
3 Arthritis Northwest, Seattle, WA,
4 Hospital for Special Surgery, New York, NY,
5 Clinical Biostatistics, Merck Research Laboratories, Rahway, NJ and
6 Pulmonary-Immunology, Merck Research Laboratories, Rahway, NJ, USA

Objectives. To evaluate the clinical efficacy and tolerability of etoricoxib in the treatment of osteoarthritis (OA) of the knee and define the clinically active dose range for further clinical trials.

Methods. This two-part, randomized, double-blind, placebo- and active comparator-controlled trial was conducted in 617 adults with knee OA. In Part 1 (6 weeks), patients received placebo, etoricoxib 5, 10, 30, 60 or 90 mg q.d. In Part 2 (8 weeks), patients received etoricoxib 30, 60 or 90 mg q.d. or diclofenac 50 mg t.i.d., predetermined at Part 1 allocation. Efficacy and safety were evaluated. Primary efficacy end-points were the Western Ontario and McMaster's University Osteoarthritis Index (WOMAC) Pain subscale, Patient Global Assessment of Response to Therapy, and Investigator Global Assessment of Disease Status.

Results. At 6 weeks, etoricoxib 5, 10, 30, 60 and 90 mg each demonstrated clinical efficacy superior to placebo. Maximal efficacy was seen with 60 mg. In Part 2, etoricoxib 30, 60 and 90 mg were generally similar to diclofenac. Patients receiving etoricoxib 30, 60 or 90 mg in Parts I and II had sustained effects over 14 weeks. All treatments were well tolerated.

Conclusions. Etoricoxib 60 mg once daily showed maximal efficacy in treating OA in this study. Etoricoxib 5–90 mg once daily was generally well tolerated in OA patients for up to 14 weeks.

KEY WORDS: Etoricoxib, Osteoarthritis, Efficacy, Safety, Tolerability.

Correspondence to: L. DeTora, Merck & Co, 126 E. Lincoln Ave., RY 32-305, Rahway, NJ 07065, USA.


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