Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
Information source: Hamamatsu University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Infections; Gastritis; Gastric Ulcer; Duodenal Ulcer
Intervention: rabeprazole, amoxicillin, clarithromycin, metronidazole (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Hamamatsu University Official(s) and/or principal investigator(s):
Naohito Shirai, MD., PhD, Study Chair, Affiliation: Hamamatsu University
Overall contact:
Naohito Shirai, MD., PhD, Phone: 81-534-2788, Email: naohito@hama-med.ac.jp
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Primary outcome: Which treatment yields the higher re-eradication rate of H. pylori infection
Secondary outcome: Side effects
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with H. pylori infection
Exclusion Criteria:
- Patients without H. pylori infection
Locations and Contacts
Naohito Shirai, MD., PhD, Phone: 81-534-2788, Email: naohito@hama-med.ac.jp
Hamamatsu University School of Medicine, Hamamatsu, Shizuoka 431-3192, Japan; Recruiting
Naohito Shirai, MD., PhD, Phone: 81-534-2788, Email: naohito@hama-med.ac.jp
Takahisa Furuta, MD., PhD, Principal Investigator
Additional Information
Starting date: August 2003
Last updated: March 20, 2006
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