Eradication of Helicobacter pylori by 7-day triple-therapy regimens combining pantoprazole with clarithromycin, metronidazole, or amoxicillin in patients with peptic ulcer disease: results of two double-blind, randomized studies

Helicobacter. 2003 Dec;8(6):626-42. doi: 10.1111/j.1523-5378.2003.00179.x.


Aim: To compare the short-term (7-day) safety and efficacy of two triple-therapy regimens using pantoprazole with those of two dual-therapy regimens (one with pantoprazole and one without), for Helicobacter pylori eradication in patients with peptic ulcer disease.

Methods: H. pylori infection was identified by rapid urease (CLOtest), and confirmed by histology and culture. Patients were enrolled into one of two randomized, double-blind, multicenter, parallel-group studies. In study A, patients received oral pantoprazole 40 mg, clarithromycin 500 mg, and metronidazole 500 mg (PCM); pantoprazole, clarithromycin and amoxicillin 1000 mg (PCA); or pantoprazole and clarithromycin (PC). In study B, patients received PCM, PCA, PC, or clarithromycin and metronidazole without pantoprazole (CM). Treatments were given twice daily for 7 days. H. pylori status after therapy was assessed by histology and culture at 4 weeks after completing the course of study treatment. Modified intent-to-treat (MITT; each study: n = 424, n = 512) and per-protocol (PP; each study: n = 371, n = 454) populations were analyzed. The MITT population comprised all patients whose positive H. pylori status was confirmed by culture and histology; the PP population comprised patients who also complied with > or = 85% of study medication doses.

Results: A total of 1016 patients were enrolled. Cure rates among patients with clarithromycin-susceptible H. pylori strains were 82 and 86% for PCM, and 72 and 71% for PCA, in studies A and B, respectively. Cure rates among patients with metronidazole-susceptible H. pylori strains were 82 and 87% for PCM, and 71 and 69% for PCA, in studies A and B, respectively. The combined eradication rates observed with the PCM regimen were superior to those of all other regimens tested. Side-effects were infrequent and mild.

Conclusions: PCM had the highest overall eradication rate in these two studies examining 7-day treatment regimens. All regimens were safe and well tolerated.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin / administration & dosage
  • Amoxicillin / adverse effects
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Anti-Ulcer Agents / administration & dosage*
  • Anti-Ulcer Agents / adverse effects
  • Benzimidazoles / administration & dosage*
  • Benzimidazoles / adverse effects
  • Clarithromycin / administration & dosage*
  • Clarithromycin / adverse effects
  • Double-Blind Method
  • Drug Resistance
  • Drug Therapy, Combination
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Male
  • Metronidazole / administration & dosage*
  • Metronidazole / adverse effects
  • Middle Aged
  • Omeprazole / analogs & derivatives
  • Pantoprazole
  • Peptic Ulcer / drug therapy
  • Peptic Ulcer / microbiology
  • Sulfoxides / administration & dosage*
  • Sulfoxides / adverse effects
  • Treatment Outcome


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Anti-Ulcer Agents
  • Benzimidazoles
  • Sulfoxides
  • Metronidazole
  • Amoxicillin
  • Pantoprazole
  • Clarithromycin
  • Omeprazole