Concomitant Therapy of H. Pylori

The Catholic University of Korea

Status and phase: Unknown; Phase 4

Conditions: Gastritis, Gastric Ulcer, and Duodenal Ulcer

Treatments: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01922765

concomitant

Details and patient eligibility

About

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.

Full 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

Enrollment: 540 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients infected with Helicobacter pylori

Exclusion criteria

• cancer
• pregnancy
• formerly treated with eradication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 4 patient groups

AOC group

Experimental group

Description:

AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days

Treatment:

Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole

AOM group

Experimental group

Description:

AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days

Treatment:

Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole

Sequential group

Experimental group

Description:

Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days

Treatment:

Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole

concomitant group

Experimental group

Description:

concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Treatment:

Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole