A multicenter, randomized, double-blind study comparing once-daily bedtime administration of famotidine and ranitidine in the short-term treatment of active duodenal ulcer.

The efficacy and safety of famotidine and ranitidine in the treatment of active duodenal ulcer were compared in a multicenter, randomized double-blind study. The study was carried out at 5 centers and involved a total of 143 patients with endoscopically documented active duodenal ulcer. The patients received either famotidine (1 40 mg tablet at night) or ranitidine 2 150 mg tablets at night). Endoscopic examinations were performed at 4 and 6 weeks of active treatment. Day and nocturnal pain were also monitored, and the laboratory and clinical profiles evaluated. One hundred and thirty-three patients fulfilled the evaluation criteria (66 patients in the famotidine group and 67 in the ranitidine group). Healing rates at weeks 4 or 6 of treatment showed no significant differences between the famotidine group and the ranitidine group. The healing rates were 78% at week 4 and 96% at week 6 in the famotidine group, and 76% at week 4 and 95% at week 6 in the ranitidine group. Similar results were observed in both treatment groups with regard to pain resolution, decrease in antacid intake and safety profile.