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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
September 12, 2005
September 20, 2005
March 21, 2006
August 2003
Not Provided
Which treatment yields the higher re-eradication rate of H. pylori infection
Which treatemt yield higher re-eradication rate of H. pylori infection.
Complete list of historical versions of study NCT00197418 on ClinicalTrials.gov Archive Site
Side effects
Same as current
Not Provided
Not Provided
 
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Helicobacter Infections
  • Gastritis
  • Gastric Ulcer
  • Duodenal Ulcer
Drug: rabeprazole, amoxicillin, clarithromycin, metronidazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
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Inclusion Criteria:

  • Patients with H. pylori infection

Exclusion Criteria:

  • Patients without H. pylori infection
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00197418
HighdosePPI
Not Provided
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Hamamatsu University
Not Provided
Study Chair: Naohito Shirai, MD., PhD Hamamatsu University
Hamamatsu University
March 2003

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