A placebo-controlled trial of floctafenine (idarac) against enteric-coated acetylsalicylic acid in osteoarthritic patients.

A double-blind placebo-controlled trial was carried out in 30 out-patients with osteoarthritis of knee and hip. The therapeutic value of flactafenine 1.2 g daily, a new oral non-narcotic analgesic agent, was compared with that of enteric-coated acetylsalicylic acid (ACSA) (Rougier Inc.--enteric-coated acetylsalicylic acid, tablets of 650 mg) 2.6 g daily. Every patient successively received the three medications for six weeks according to a Latin-square design. An objective index of improvement of hips and knees was developed and applied to this study. In both objective and subjective assessments of the disease, floctafenine was found to be approximately equivalent to or superior to ACSA and superior to placebo. Both drugs were clinically well tolerated. A consistant but slight decrease in both haemoglobin and red-blood-cell count under floctafenine and ASA was found to be statistically but not clinically significant.