Double-blind multicenter study comparing meclofenamate sodium with indomethacin and placebo in the treatment of extra-articular rheumatic disease

• Published in: Arzneimittel-Forschung Vol. 33; no. 4A; p. 649
• Main Authors: Boussina, I, Günthner, W, Martí Massó, R
• Format: Journal Article
• Language: English
• Published: Germany 1983
• Subjects: Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Indomethacin - adverse effects; Indomethacin - therapeutic use; Male; Meclofenamic Acid - adverse effects; Meclofenamic Acid - therapeutic use; Middle Aged; ortho-Aminobenzoates - therapeutic use; Placebos; Rheumatic Diseases - drug therapy
• ISSN: 0004-4172

161 patients with extra-articular or non-articular disorders as acute shoulder syndrome, periarthritis humero scapularis, syndrome of the angular of the scapula, acute olecranon bursitis, acute epicondylitis and/or epitrochleitis or periarthritis of the hip were treated in this double-blind multicenter study. 53 patients received 300 mg N-(2,6-dichloro-m-tolyl)anthranilic acid, sodium salt (meclofenamate sodium, Meclomen) per day for a maximum of 3 weeks, 54 received 150 mg indomethacin per day and 54 received placebo. Meclofenamate sodium was significantly superior to placebo in the treatment of such symptoms as spontaneous pain, pain on motion, tenderness on pressure associated with acute episodes of extra- or non-articular rheumatism as demonstrated by earlier and superior improvement. Indomethacin showed comparable efficacy. Adverse reactions, mostly gastrointestinal symptoms, were reported by 15 patients receiving meclofenamate sodium (28.3%), 26 patients taking indomethacin (48.2%) and 5 patients in the placebo group (9.3%). The tolerance of meclofenamate sodium was good with the distinct clinical impression that meclofenamate sodium was better tolerated than indomethacin.