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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2003 by Hamamatsu University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197418
First Posted: September 20, 2005
Last Update Posted: March 21, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hamamatsu University
  Purpose

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.


Condition Intervention Phase
Helicobacter Infections Gastritis Gastric Ulcer Duodenal Ulcer Drug: rabeprazole, amoxicillin, clarithromycin, metronidazole Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • Which treatment yields the higher re-eradication rate of H. pylori infection

Secondary Outcome Measures:
  • Side effects

Study Start Date: August 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with H. pylori infection

Exclusion Criteria:

  • Patients without H. pylori infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197418


Contacts
Contact: Naohito Shirai, MD., PhD 81-534-2788 naohito@hama-med.ac.jp

Locations
Japan
Hamamatsu University School of Medicine Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Naohito Shirai, MD., PhD    81-534-2788    naohito@hama-med.ac.jp   
Principal Investigator: Takahisa Furuta, MD., PhD         
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Naohito Shirai, MD., PhD Hamamatsu University
  More Information

ClinicalTrials.gov Identifier: NCT00197418     History of Changes
Other Study ID Numbers: HighdosePPI
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: March 21, 2006
Last Verified: March 2003

Keywords provided by Hamamatsu University:
H. pylori infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Ulcer
Gastritis
Stomach Ulcer
Duodenal Ulcer
Helicobacter Infections
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Metronidazole
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors