Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
NCT ID: NCT00197418
Last Updated: 2006-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
INTERVENTIONAL
2003-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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rabeprazole, amoxicillin, clarithromycin, metronidazole
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
90 Years
ALL
No
Sponsors
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Hamamatsu University
OTHER
Principal Investigators
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Naohito Shirai, MD., PhD
Role: STUDY_CHAIR
Hamamatsu University
Locations
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Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HighdosePPI
Identifier Type: -
Identifier Source: org_study_id