A randomised double-blind multicentre trial comparing tenoxicam and ketoprofen in osteoarthritis.

A double-blind multicentre study was conducted to compare the efficacy and safety of tenoxicam and ketoprofen in the treatment of osteoarthritis (OA). The study comprised 307 patients and the treatment period was 12 weeks. One-hundred and fifty-five patients received 20 mg tenoxicam once-daily and 152 patients received 100 mg ketoprofen b.i.d. Seventy-seven patients were prematurely withdrawn; 32 patients in the tenoxicam group and 45 in the ketoprofen group (p less than 0.05). There were only small insignificant differences in the efficacy parameters with the exception that significantly more patients in the tenoxicam group took paracetamol tablets during treatment. Adverse events developed in 29.0% of the patients on tenoxicam and in 47.3% of the patients on ketoprofen, this difference was statistically significant (p less than 0.05). The adverse events were predominantly from the gastrointestinal tract and the central nervous system. No serious side-effects occurred and the laboratory parameters showed no clinically relevant changes. The investigator's overall impression of treatment showed no significant difference between groups. Excellent or good results were judged in 55.2% of the patients on tenoxicam and in 62.1% on ketoprofen (p greater than 0.05). Tenoxicam appears to have a reasonable balance between efficacy and side-effects in the treatment of OA.