[Double-blind controlled-clinical trials of lansoprazole in the treatment of peptic ulcer]

Abstract

Two multicentre clinical trials of lansoprazole, a new proton pump inhibitor, were completed in patients with gastric and duodenal ulcer. Double-blind comparative studies with a beta-blocker, famotidine, in gastric ulcer (study 1) and in duodenal ulcer (study 2) were conducted. Study 1. A total of 316 cases of gastric ulcer, 158 for lansoprazole, 158 for famotidine were treated for eight weeks and the bollowing observed. Healing rates by endoscopic findings were 90% for lansoprazole and 72% for famotidine respectively, with a significant difference (p less than 0.01). Adverse events were observed in five cases in lansoprazole group, six cases in the famotidine group. Study 2. A total of 291 cases of duodenal ulcer, 148 for lansoprazole, 143 for famotidine, were treated for six weeks. Healing rates by endoscopic fendings were 92% for lansoprazole and 85% for famotidine respectively. Adverse effects were observed in 5.3% in the lansoprazole group, and 5.5% in the famotidine group.