Gastritis Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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