Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections

Study Overview
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Brief Summary
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This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.

Detailed Description
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Background: Antimicrobial resistance has decreased the worldwide eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%). Objective: To determine the optimal pre-concommitant treatment length for rabeprazole based sequential-concomitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Design: Randomized, open-label, prospective controlled trial. Patients: 231 patients with dyspepsia or peptic ulcers and infected by Helicobacter pylori. Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host. Intervention: 231 patients with Helicobacter pylori infection are recruited and randomly assigned to receive one of the following therapeutic schemes: group 1, 14-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 2, 12-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 3, 10-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days. Repeat upper endoscopy for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of treatment to assess the treatment result. The influence on the hybrid therapies of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined. Expected results: The rabeprazole based sequential-concomitant therapies for eradication of Helicobacter pylori is very effective, and the outcome is not affected by antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host.

Official Title
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Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: RA5-RACM7
* Drug: RA3-RACM7
* Drug: RA7-RACM7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient proved with infection of H. pylori in gastric mucosa (at least two of four tests positive) Exclusion Criteria: woman in breast feeding or pregnancy. allergy to drugs used in study. previously treated for H. pylori. intolerance to fructose, lactose. patients with hematologic, brain or spinal disorders patients under 20 years old patients under aspirin or clopidogrel patients with history of gastric cancer or gastric resection operation.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid-10<br>RA3-RACM7: rabeprazole + amoxicillin x 3 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days. | Drug: RA3-RACM7<br>* rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days<br>* Other names: Flagyl x 7 days.;|
| Experimental: Hybrid-12<br>RA5-RACM7: rabeprazole + amoxicillin x 5 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days | Drug: RA5-RACM7<br>* rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days<br>* Other names: Flagyl x 7 days.;|
| Experimental: Hybrid-14<br>RA7-RACM7: rabeprazole + amoxicillin x 7 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days | Drug: RA7-RACM7<br>* rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days<br>* Other names: Flagyl x 7 days.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment. | 4 weeks after complete use of drug for treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, antibiotic resistance, sequential-concomitant hybrid therapy