Famotidine once-a-day in the therapy of acute, benign gastric ulcer: a worldwide experience.

Three hundred thirty-six patients with endoscopically diagnosed benign gastric ulcers, randomly allocated to treatment with 40 mg famotidine at night or placebo, were evaluated in a double-blind multicenter trial conducted in 14 countries worldwide. After 4 weeks, 294 patients qualified for a "per protocol" analysis. Complete ulcer healing was observed in 70 of 149 patients (47%) treated with famotidine 40 mg at night and in 45 of 145 patients (31%) receiving placebo. Cumulative healing rates at 6 weeks were 65 and 46%, and at 8 weeks 80 and 54%, respectively. There were statistically significant differences between the healing rates at each time point (p less than 0.01). The famotidine treatment was significantly more effective at rapidly reducing the incidence of ulcer-related symptoms. Adverse side effects reported were minor and equally distributed between the two groups. The results of this trial show that 40 mg famotidine administered at night is significantly superior to placebo in both accelerating the healing of benign gastric ulcers and in relieving ulcer symptoms. Since 40 mg famotidine administered at night suppresses exclusively nocturnal acid secretion, these findings support the hypothesis that this factor is also of particular importance in the pathogenesis of gastric ulcers.