A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients

Background. Two triple therapies with lansoprazole (LPZ)/amoxicillin (AMPC) /clarithromycin (CAM) for eradication of Helicobacterpylori were studied in multicenter, double-blind fashion to evaluate the eradication rate of H. p ylori and safety of eradiation treatment in Japanese patients with H. pylor i-positive active gastric ulcers or duodenal ulcers. Methods. Patients were randomly chosen for the control treatment of LPZ 30 mg twice a day (b.i.d.; Group A-LPZ-only) or the test treatments of LPZ 30 mg plus AMPC 750 mg and CAM 200 mg b.i.d. (Group B-LAC200) and LPZ 30 mg, A MPC 750 mg and CAM 400 mg b.i.d. (Group C-LAC400). All eradication treatmen ts lasted for a period of 7 days. Successful eradication was assessed by cu lture and gastric histology I month after completion of the ulcer treatment . Results. The eradication rates of H. pylori in the full analysis set were 0 % in Group A-LPZ-only, 87.5% in Group B-LAC200 and 89.2% in Group C-LAC400 for gastric ulcer and, 4.4% in Group A-LPZ-only, 91.1% in Group B-LAC200 an d 83.7% in Group C-LAC400 for duodenal ulcer. The eradication rates of Grou p B-LAC200 and Group C-LAC400 were 89.2% (95% Ch 84.8-93.7%) and 86.4% (95% CI: 81.5-91.3%) in total in the full analysis set, 89% (95% CI: 84.3-93.7% ) and 85.3% (95% CI: 80.1-90.5%) in the per protocol set. The eradication r ates in Groups B-LAC200 and group C-LAC400 were statistically significantly higher than the rate in Group A-LPZ-only for both gastric ulcer and duoden al ulcer patients (p < .0001 for both). Conclusion. A satisfactorily high H. pylori eradication rate was obtained i n Japanese ulcer patients with the triple therapy regimen consisting of LPZ 30 mg, AMPC 750 mg, and CAM 200 mg b.i.d.