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| Sponsored by: |
Hamamatsu University |
|---|---|
| Information provided by: | Hamamatsu University |
| ClinicalTrials.gov Identifier: | NCT00197418 |
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 II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study |
| 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 |
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Naohito Shirai, MD., PhD | 81-534-2788 | naohito@hama-med.ac.jp |
| Japan, Shizuoka | |
| 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 | |
| Study Chair: | Naohito Shirai, MD., PhD | Hamamatsu University |
More Information
| Study ID Numbers: | HighdosePPI |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00197418 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
H. pylori infection |
|
Stomach Ulcer Bacterial Infections Metronidazole Amoxicillin Gastrointestinal Diseases Ulcer Helicobacter Infections Intestinal Diseases Gram-Negative Bacterial Infections |
Duodenal Ulcer Clarithromycin Digestive System Diseases Stomach Diseases Gastroenteritis Gastritis Rabeprazole Peptic Ulcer Duodenal Diseases |
|
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors Infection |
Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Antiparasitic Agents Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Anti-Ulcer Agents |
