MULTICENTRE STUDY OF PIROXICAM VERSUS NAPROXEN IN JUVENILE CHRONIC ARTHRITIS, WITH SPECIAL REFERENCE TO PROBLEM AREAS IN CLINICAL TRIALS OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS IN CHILDHOOD

Abstract

Clinical trials of nonsteroidal anti-inflammatory drugs (NSAIDs) are necessary in juvenile chronic arthritis (JCA) but pose certain problems highlighted and discussed in this study, including recruitment, the assessment of efficacy, and the heterogeneity of the disease. In a multicentre 8-week double-blind cross-over study using the double-dummy technique, piroxicam was compared with naproxen in 47 children with seronegative JCA aged 5-16 years. No significant difference between the two treatments was found in either the clinical variables measured or the parent/patient and physician preference at the end of the study. Side-effect profiles of the two drugs were similar, mainly gastrointestinal disturbances. Piroxicam may be a useful alternative NSAID in JCA, particularly in view of its once-daily dosage.