search
Back to results

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
Hamamatsu University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Infections focused on measuring H. pylori infection

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
March 20, 2006
Sponsor
Hamamatsu University
search

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

We'll reach out to this number within 24 hrs