Treatment of duodenal ulcer with ranitidine, a new histamine H2-receptor antagonist.

Fifty patients with endoscopically verified duodenal ulcer were treated with either 100 mg of ranitidine hydrochloride (corresponding to 89.4 mg of ranitidine base) or identical placebo tablets twice daily under double-blind conditions. One patient did not attend for the second endoscopy and was excluded. Endoscopic examination after 4 weeks of treatment showed that the ulcer had healed in 23 out of 25 patients (92%) treated with ranitidine and in 11 out of 24 patients (46%) treated with placebo (P < 0.01). The ranitidine-treated patients had significantly less ulcer symptoms during treatment. Antacid consumption was also less in the ranitidine than in the placebo-treated group, but the difference was not significant. After 4 weeks in the double-blind study 14 of the 15 patients with unhealed ulcer received open treatment with ranitidine for 4-6 weeks. The ulcer healed in all but one patient. No serious side effects of ranitidine were observed.