Abstract
A multicenter, double-blind, cross-over, random-order study compared the efficacy of floctafenin, 800 mg/day and acetaminophen, 3 000 mg/day, in providing pain relief to 192 patients with chronic pain due to osteoarthritis in the lower limbs. Each drug was given for 12 days and the interval between the two treatment periods was two days. The primary evaluation criterion was pain relief as assessed using the visual analog scale developed by Huskisson (mean baseline score, 62.7+/-13.6 mm). Secondary criteria were the algofunctional index, the investigator's overall efficacy rating and patient preference. Floctafenin therapy was associated with significantly better results regarding the visual analog scale score (P = 0.036, 149 patients in the per protocol analysis) and the investigator's overall efficacy rating (P = 0.0001, 169 evaluable patients). Among the 169 evaluable patients, 68 had no preference for either treatment and 101 had a preference, which was for floctafenin therapy in 65% of cases (P = 0.001). Clinical tolerance was satisfactory with both drugs. Gastrointestinal symptoms were the most common side effects (13% and 11% of patients with floctafenin and acetaminophen,respectively).