NCT01566643

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	RA5-RACM7	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
DRUG	RA3-RACM7	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
DRUG	RA7-RACM7	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

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-29
• Last updated: 2012-04-05

Locations

1 site across 1 country: Taiwan