Roxatidine acetate is a new H2-receptor antagonist. A randomized double-blind clinical trial in fifty-three patients with endoscopically proven duodenal ulcers > 5 mm in diameter was undertaken to compare safety and efficacy of roxatidine with that of ranitidine. Twenty-six patients received roxatidine (75 mg bid) while 27 patients received ranitidine (150 mg bid) for 4 weeks. One patient in each group did not come for follow up. Roxatidine and ranitidine had comparable ulcer healing rates (22/25 vs 22/26); roxatidine, however, resulted in greater reduction in the number and severity of night time pain episodes (p < 0.05). No adverse event was reported during 4 weeks of treatment with roxatidine. Thus roxatidine achieves the primary therapeutic goal of relief of pain better than ranitidine.