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

NCT00197418 | Unknown Phase 2

• 1 other identifier: HighdosePPI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Infections; Gastritis; Gastric Ulcer; Duodenal Ulcer

Keywords

H. pylori infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Side effects

Interventions

rabeprazole, amoxicillin, clarithromycin, metronidazole DRUG

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with H. pylori infection

You may not qualify if:

• Patients without H. pylori infection

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

MeSH Terms

Conditions

Helicobacter Infections; Gastritis; Stomach Ulcer; Duodenal Ulcer

Interventions

Rabeprazole; Amoxicillin; Clarithromycin; Metronidazole

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Naohito Shirai, MD., PhD

  Hamamatsu University

  STUDY CHAIR

Central Study Contacts

Naohito Shirai, MD., PhD

CONTACT

81-534-2788; naohito@hama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2003
• Last Updated: March 21, 2006

Record last verified: 2003-03

Locations

JP (1)