Methods: 945 outpatient s from 21 centres in 14 countrie s received racecadotri l (100 mg) or loperamide (2 mg) three times daily in a single-blin d study. Duration of diarrhoea was the primary measure of efficacy; secondary criteria were overall clinicalresponse , occurrence and duration of abdominal pain and distension, and occurrence of other associated signs and symptoms. Occurrence of constipation and adverse events were the main safety assessments.