Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
Primary Purpose
Helicobacter Infections, Gastritis, Gastric Ulcer
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
rabeprazole, amoxicillin, clarithromycin, metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Infections focused on measuring H. pylori infection
Eligibility Criteria
Inclusion Criteria: Patients with H. pylori infection Exclusion Criteria: Patients without H. pylori infection
Sites / Locations
- Hamamatsu University School of MedicineRecruiting
Outcomes
Primary Outcome Measures
Which treatment yields the higher re-eradication rate of H. pylori infection
Secondary Outcome Measures
Side effects
Full Information
NCT ID
NCT00197418
First Posted
September 12, 2005
Last Updated
March 20, 2006
Sponsor
Hamamatsu University
1. Study Identification
Unique Protocol Identification Number
NCT00197418
Brief Title
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
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 Type
Interventional
2. Study Status
Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamamatsu University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infections, Gastritis, Gastric Ulcer, Duodenal Ulcer
Keywords
H. pylori infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rabeprazole, amoxicillin, clarithromycin, metronidazole
Primary Outcome Measure Information:
Title
Which treatment yields the higher re-eradication rate of H. pylori infection
Secondary Outcome Measure Information:
Title
Side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with H. pylori infection
Exclusion Criteria:
Patients without H. pylori infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naohito Shirai, MD., PhD
Phone
81-534-2788
Email
naohito@hama-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naohito Shirai, MD., PhD
Organizational Affiliation
Hamamatsu University
Official's Role
Study Chair
Facility Information:
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naohito Shirai, MD., PhD
Phone
81-534-2788
Email
naohito@hama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Takahisa Furuta, MD., PhD
12. IPD Sharing Statement
Learn more about this trial
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
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