Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
Study Overview
Brief Summary
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.
Detailed Description
- Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
- 170 subjects per group
- Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients infected with Helicobacter pylori
Exclusion Criteria
- •pregnancy
- •formerly treated with eradication
Arms & Interventions
AOC group
AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
AOM group
AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
Sequential group
Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
concomitant group
concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
Outcomes
Primary Outcomes
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
Time Frame: 6 months (Feb 2014)
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Jin Il Kim
MD, PhD
The Catholic University of Korea