Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection

Dual Therapy With High-Dose of Rabeprazole and Amoxicilline Versus Triple Therapy With Rabeprazole, Amoxicilline and Metronidazole as the Second Line Therapy for the Cure of H. Pylori Infection

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197418

Enrollment

Unknown

Registered

2005-09-20

Start date

2003-08-31

Completion date

Unknown

Last updated

2006-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Ulcer, Gastric Ulcer, Gastritis, Helicobacter Infections

Keywords

H. pylori infection

Brief summary

Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme activities. The most essential role of a PPI in H. pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels. Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H. pylori. Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19. Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also achieved high eradication rates and has been recommended as the second line therapy in Japan. But carcinogenic actions of MNZ have been unclear. The purpose of this study is to compare the re-eradication rates of H. pylori infection by the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the efficacies of these re-eradication regimens as second line eradication therapies.

Interventions

DRUGrabeprazole, amoxicillin, clarithromycin, metronidazole

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients with H. pylori infection

Exclusion criteria

* Patients without H. pylori infection

Design outcomes

Primary

Measure	Time frame
Which treatment yields the higher re-eradication rate of H. pylori infection	—

Secondary

Measure	Time frame
Side effects	—

Countries

Japan

Contacts

Primary ContactNaohito Shirai, MD., PhD

naohito@hama-med.ac.jp81-534-2788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026