Double-blind study of ketoprofen against a placebo in osteoarthritis of the hip

Abstract

In this trial, the patients suffering from osteoarthritis of the hip received either ketoporfen or a placebo successively for 2 treatment periods, A and B, of 14 days each. The daily dosage of ketoprofen was 150 mg in 3 doses of 50 mg. In each case treated, the parameters necessary for the diagnosis and those necessary to assess progress under treatment are reported. At the end of the trial, results have been rated according to the preference of the patient for treatment period A or B. The results were analysed by the sequential method. The therapeutic results reported were obtained from various criteria stated in the protocol (subjective evaluation by the patient, pain when resting, duration of morning stiffness, distance of pain-free walking, amplitude of movements, etc.). Nine cases were sufficient to produce a significant statistical result in favour of ketoprofen. In eight observations a preference in favour of ketoprofen was apparent. In one case only, there was no preference for either one or the other of the two treatment periods (failure of ketoprofen and of the placebo). Ketoprofen was excellently tolerated.