Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

March 20, 2006

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Which treatment yields the higher re-eradication rate of H. pylori infection

Original Primary Outcome Measures ^ICMJE

Which treatemt yield higher re-eradication rate of H. pylori infection.

Change History

Complete list of historical versions of study NCT00197418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side effects

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Helicobacter Infections
Gastritis
Gastric Ulcer
Duodenal Ulcer

Intervention ^ICMJE

Drug: rabeprazole, amoxicillin, clarithromycin, metronidazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with H. pylori infection

Exclusion Criteria:

Patients without H. pylori infection

Gender

Both

Ages

20 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Naohito Shirai, MD., PhD

81-534-2788

naohito@hama-med.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00197418

Responsible Party

Study ID Numbers ^ICMJE

HighdosePPI

Study Sponsor ^ICMJE

Hamamatsu University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Naohito Shirai, MD., PhD

Hamamatsu University

Information Provided By

Hamamatsu University

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP