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Clinical Trials/NCT01922765
NCT01922765UnknownPhase 4

Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori

The Catholic University of Korea1 site in 1 country540 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)

AOM group

Experimental

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

Intervention: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)

Sequential group

Experimental

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

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin Il Kim

MD, PhD

The Catholic University of Korea

Study Sites (1)

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