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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00197418
• Other study ID #: HighdosePPI
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: March 20, 2006
• Start date: August 2003

Study information

• Verified date: March 2003
• Source: Hamamatsu University
• Contact: Naohito Shirai, MD., PhD
• Phone: 81-534-2788
• Email: naohito[@]hama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with H. pylori infection

Exclusion Criteria:

• Patients without H. pylori infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Duodenal Ulcer
• Gastric Ulcer
• Gastritis
• Helicobacter Infections
• Infection
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• rabeprazole, amoxicillin, clarithromycin, metronidazole

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Which treatment yields the higher re-eradication rate of H. pylori infection
Secondary	Side effects