Treatment of osteoarthritis is usually symptomatic; however growing interest is being raised on NSAIDs action over articular cartilage. Aceclofenac has been shown in vitro to play a favorable role over articular cartilage, increasing GAG synthesis. Preclinical and clinical studies have shown aceclofenac to be better tolerated than others in the same therapeutic class. Considering this, it was decided to conduct a multicenter study of aceclofenac in management of knee osteoarthritis. Five centers participated evaluating a total of 97 patients. Most of the patients showed clear clinical improvement, demonstrating a good potency profile. The results allow us to say that in this clinical study aceclofenac was shown to be safe and well tolerated.543150157Grau, M., Montero, J.L., Guasch, J., Felipe, A., Carrasco, E., Juliá, S., The parmacological profile of aceclofenac, a new nonsteroidal, antiinflammatory and analgesic drug (1991) Agents and Actions Drugs in Inflammation, 32, pp. 125-129Grau, M., Guasch, J., Monteiro, J.L., Felipe, A., Carrasco, E., Juliá, S., The Pharmacology of potent new nonsteroidal antiinflammatory agent: Acecloferiac (1991) Arznein. Forsch./Drug Res., 41 (2), pp. 1265-1276. , 12Winter, C.A., Risley, E.A., Nuss, G.W., Carrageenin-induced edema in hind paw of the rat as an assay for antiinfiammatory drugs (1962) PSEMB, 111, pp. 544-547Berutz, K.F., Hall, L.M., The carregeenin-induced abscess as a new test for antiinflammatory activity of steroids and nonsteroids (1963) Arch Int. Pharmacodyn., 144, pp. 185-195Vinegar, R., Truax, J.F., Selph, J.L., Johnston, P.R., Venable, A.L., Voelker, F.A., Development of carrageenin pleurisy in the rat: Effects os colchicine on inhibition of cell mobilization (1981) PSEBM, 168, pp. 24-32Whittle, B.A., The use changes in capillary permeability in mice to distinguish between narcotic and nonarcotic analgesics (1964) Brit J. Pharmacol., 22, pp. 246-253Niemergeers, C.J.E., Janssen, P.A.J., Suprofen, a potent antagonist of sodium urate crystal-induced arthritis in dogs (1975) Arzneim Forsch, 25 (10), pp. 1512-1515Winter, C.A., Porter, C.C., Effect of alterations in side chain upon antiinflammatory and liver glycogen activities of hydrocortisone esters (1957) J Amer Pharmacol Assoc., 46 (9), pp. 515-519Pearson, C.M., Development of arthritis, periarthritis and periostitis in rats given adjuvant (1965) PSEMB, 91, pp. 95-100Hendershot, L.C., Forsaith, J., Antagonism of frequency of phenylquinone-induced writing in the mouse by weak analgesics and nonalgesics (1959) J. Pharmacol Exp Ther, 125, pp. 237-240Randall, L.O., Sellito, J.J., A method for measurement of analgesic activity on inflamed tissue (1957) Arch Int. Pharmacodyn, 11 (4), pp. 409-419LaBelle, A., Tislow, R., A method of evaluating analgesics of the antiarthralgic type in the laboratory animal (1950) J. Pharmacol Exp Ther, 98, p. 19Rouvix, B., Test de l'hypertemie induite par la levure chez le rat. Fiche Techinique no 50 (1980) J. Pharmacol, 11, pp. 133-136. , ParisFord-Hutchinson, A.W., Walker, J.R., Smith, M.J.H., Assessment of anti-inflammatory activity by sponge implantation techniques (1978) J. Pharmacol Methods, 1, pp. 3-7Smith, J.B., Ingerman, C.M., Silver, M.J., Malondialdehyde formation as an indicator of prostal-glandin production by human platets (1976) J. Lab. Clin. Med., 88 (1), pp. 167-172Cecchetin, M., Cerea, P., Torn, G., Therapeutic efficacy of Aceclofenac and Diclofenac in acute knee arthroses. A study of E2-prostaglandin levels in synovial fluid and in serum (1988) Clinical Trials Journal, 25 (2), pp. 144-151Abramson, S.B., Weissmann, G., The mechanisms of action of nonsteroidal antiinflammatory drugs (1989) Arthritis and Rheumatism, 32 (1), pp. 1-9Halliwell, B., Hoult, J.R., Blake, D.R., Oxidants, inflammation and antiinflammatory drugs (1988) FASEB J., 2, pp. 2867-2873Aruoma, O.I., Halliwell, B., The iron binding and hydraxyl radical scavening action of antiinflammatory drugs (1988) Xenobiotoca, 18 (4), pp. 459-470Schoen, R.T., Vender, R.J., Mechanisms of nonsteroidal antiinflammatory drug-induced gastric damage (1989) Am J. Med, 86, pp. 449-458Adami, E., Marazzi-Uberti, E., Turba, C., Pharmacological research on gefarnate, a new synthetic isoprenoid with antiulcer action (1964) Arch. Int. Pharmacodyn, 147 (1-2), p. 112Del Soldato, P., Meli, A., Volterra, G., Influence of fasting and cimetidine on the relationship between ulcerogenic and anti-inflammatory properties of indomethacin (1979) Br J Pharmac, 67, pp. 33-37Whitlle, B.J.R., Role of prostaglandins in defense of the gastric mucosa (1980) Brain Research Bulletin, 5 (1 SUPPL.), pp. 7-14Volterra, G., Pisanti, N., Mell, A., Factors influencing the development of indomethacin-induced intestinal ulcers in the rat (1975) PSEMB, 146, pp. 146-152Rimbau, V., Fernández, M.F., Guirao, I., Torralba, A., Izquierdo, E., Comparative study of gastrintestinal tolerance of diclofenac and aceclofenac (1988) Il Farmaco, 43 (1), pp. 19-26Irwin, S., Comprehensive observational assessment 1a. A systematic, quantitative procedure for assessing the behavioral and physiologic state of the mouse (1968) Psychopharmacologia, 13, p. 222Guash, J., Felipe, A., (1983) Estudlos de Toxicidad Aguda del Aceclofenaco, , Departamento de Toxicologia. Centro de Investigación de Prodesfarma. Informe internoMarinelli, P., (1991) Aceclofenac: 4-week Oral Toxicity Study in Rats Followed by 4 Weeks of Recovery, , Instituto de Recerche Biomediche Antoine Marxer. Informe internoMarinelli, P., (1991) Acecloferiac: 26 Week Oral Toxicity in Rats, , Instituto di Recerche Biomediche Antoine Marxer. Informe internoZapatero, J., (1986) Estudio de Toxicidad de Trece Semanas de Duración en Mono Cynomolgus (Macaca Fascicularis), , Centro de Investigación y Desarrollo Aplicado. Informe internoZapatero, J., (1987) Estudio de Toxicidad de Cincuenta Semanas de Duración en Mono Cynomolgus (Macaca Fascicularis), , Centro de Investigatión y Desarrollo Aplicado. Informe interneZapatero, J., (1989) Estudio Sobre la fer Tilidad y Capacidad de Reproducción General en Ratas. SustanciaAce-clefenaco, , Centro de Investigatión y Desarrollo Aplicado Informe interneZapatero, J., (1991) Estudio de Teratogenia en Ratas. Sustancia Ensayada: Aceclofenaco, , Centro de Investigación y Desarrollo Aplicado. Informe intemoKing, V.C., (1991) Aceclofenac: Teratology Study in the Rabbit, , Life Science Research Limited. Informe internoZapatero, J., (1991) Estudio de Toxicidad Peri y Post-natal en Ratas. Producto a Ensayar: Aceclofenaco, , Centro de Investigación y Desarrollo Aplicado. Informe internoLlagostera, M., Guerrero, G., (1985) Test de Mutaciones de Capas Bacterianas (Test de Ames), , Departamento de Microbiología. Facultat de Ciências. Universidad Autónoma de Barcelona. Informe internoGarcía, M., Montero, R., (1986) Test de Intercambio de Cromátidas Hermanas en Linfocitos Humanos, , Instituto de Biologia Fundamental "V. Villar Palasi". Departamento de Biología Celular y Fisidogia. Universidad Autónoma de Barcelona. Informe internoZapatero, J., (1991) Test de Inducción de Aberraciones Cromosómicas en Lifoncitos Humanos, , Centro de Investigación y Desarrollo Aplicado. Informe internoBatiste-Alertorn, M., (1987) Test de Mutaciones Letales Recesivas Ligadas Al Sexo en la Drosophila Melanogaster, , Departamento de Genética. Facultad de Clencias. Universidad Autónoma de Barcelona Informe internoGuasch, J., Felipe, A., (1987) Test de Los Micronúcleos en Ratón, , Departamento de toxicología. Centro de Investigación de Prodesfarma. Informe internoGur, E., Myska, A., Waner, T., Crown, S., (1991) Aceclofenac: 18-month Oncogenicity Study in the Mouse by Dietary Administration, , Life Science Research Israel Ltd. Informe internoZapatero, J., Estudio Carcinogenético del Aceclofenaco Administrado Durante 24 Meses a Ratas Por Via Oral, , Centro de Investigación y Desarrollo Aplicado. Informe interne(1992) European Journal of Rheumatism and Inflammation, 12, pp. 3-8Dingle, J.T., Horner, A., Shield, M., (1991) Cell Biochemical Function, 9, pp. 99-102Dingle, J.T., The effect of NSAIDs on human articular cartilage glycosaminoglycan synthesis (1996) European Journal of Rheumatism and Inflammation, 16, pp. 47-52Torri, G., Efficacy and tolerability of aceclofenac in treatment of gonalgia: Controlled double-blind study vs. diclofenac (1987) Curr. Ther. Res., 42, pp. 453-457Cecchetin, M., Cerea, P., Torri, G., Therapeutic efficacy of aceclofenac an diclofenac in acute knee arthrosis. A study of prostaglandin E2 levels in synovial fluid and serum (1988) Clin Trials J, 25, pp. 144-151Diaz, C., Rodriguez, A., Celi, C., Llobet, J.M., Tapounet, R., Comparison of aceclofenac and diclofenac in osteroathritic pain (1988) Curr. Ther. Res., 44, pp. 252-256Giorgiani, G., Otaviani, C., Soliano, A., Campi, N., Evaluación de la eficacia y tolerancia del aceclofenaco frente ao cetoprofeno en el tratamiento de la artitis reumatoidea (1992) Curr. Ther. Res., 51 (2), pp. 175-184