A total of 179 Filipino patients aged 20-70 years each with at least one symptomatic duodenal ulcer > 5 mm in diameter were randomized to receive treatment with either omeprazole (OME) 20 mg once in the morning or ranitidine (RAN) 300 mg once at night for 2-4 weeks, depending on healing. At entry, ulcers > 10 mm were found in 64% of OME and 61% of RAN patients. After 2 weeks, per protocol (PP) healing rates were 73/88 (83%) for OME and 28/88 (32%) for RAN (chi-2 test: P < 0.001, 95% confidence interval of true difference 37-65%). After 4 weks, cumulative PP healing rates were 85/88 (97%) for OME and 64/87 (74%) for RAN (chi-2 test: P < 0.001, 95% confidence interval of true difference 12-34%). A logit analysis showed that OME treatment and small ulcer size significantly increased the odds of healing, but smoking had no significant effect. Patients on OME experienced significantly fewer days (P = 0.0001) and nights (P = 0.0001) of epigastric pain during the first 2 weeks than patients on RAN. Only one patient, with previously undiagnosed pancreatic cancer, reported adverse events and no clinically significant changes in laboratory variables were recorded.