A Multicenter, Double-Blind Study on Triple Therapy With Lansoprazole, Amoxicillin and Clarithromycin for Eradication of Helicobacter Pylori in Japanese Peptic Ulcer Patients

Helicobacter. 2001 Sep;6(3):254-61. doi: 10.1046/j.1523-5378.2001.00037.x.

Abstract

Background: Two triple therapies with lansoprazole (LPZ)/amoxicillin (AMPC)/clarithromycin (CAM) for eradication of Helicobacter pylori were studied in multicenter, double-blind fashion to evaluate the eradication rate of H. pylori and safety of eradiation treatment in Japanese patients with H. pylori-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, AMPC 750 mg and CAM 400 mg b.i.d. (Group C-LAC400). All eradication treatments lasted for a period of 7 days. Successful eradication was assessed by culture and gastric histology 1 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 and 83.7% in Group C-LAC400 for duodenal ulcer. The eradication rates of Group B-LAC200 and Group C-LAC400 were 89.2% (95% CI: 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 rates 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 duodenal ulcer patients (p <.0001 for both).

Conclusion: A satisfactorily high H. pylori eradication rate was obtained in Japanese ulcer patients with the triple therapy regimen consisting of LPZ 30 mg, AMPC 750 mg, and CAM 200 mg b.i.d.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adult
  • Amoxicillin / administration & dosage*
  • Amoxicillin / adverse effects
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / therapeutic use*
  • Clarithromycin / administration & dosage*
  • Clarithromycin / adverse effects
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination / administration & dosage
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / therapeutic use
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori* / drug effects
  • Humans
  • Lansoprazole
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Multicenter Studies as Topic
  • Omeprazole / administration & dosage
  • Omeprazole / adverse effects
  • Omeprazole / analogs & derivatives*
  • Omeprazole / therapeutic use*
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / microbiology

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Lansoprazole
  • Amoxicillin
  • Clarithromycin
  • Omeprazole