A multi-centre trial was carried out in 1629 patients with osteoarthrosis in 233 clinical centres to investigate the therapeutic efficacy and tolerability of indoprofen in this clinical condition. The results from assessments of both subjective and objective variables were comparable to those obtained in Phase 3 studies. Moreover, 87.2% of patients expressed a 'good' or 'very good' opinion on the product's efficacy after treatment, usually with 3 tablets (600 mg) daily for 4 weeks. The benefit/risk relationship was confirmed as very favourable on account of the marked activity of the drug and the acceptable frequency of adverse reactions, which were mainly subjective and slight and confined to the gastro-intestinal tract.