Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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 |
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with H. pylori infection
Exclusion Criteria:
- Patients without H. pylori infection
Contacts and Locations| Contact: Naohito Shirai, MD., PhD | 81-534-2788 | naohito@hama-med.ac.jp |
| 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 | |
| Study Chair: | Naohito Shirai, MD., PhD | Hamamatsu University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00197418 History of Changes |
| Other Study ID Numbers: | HighdosePPI |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 20, 2006 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Hamamatsu University:
|
H. pylori infection |
Additional relevant MeSH terms:
|
Gastritis Duodenal Ulcer Stomach Ulcer Ulcer Helicobacter Infections Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Stomach Diseases Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections |
Amoxicillin Clarithromycin Metronidazole Rabeprazole Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013