Concomitant Therapy of H. Pylori

Phase 4

• Conditions: Gastritis, Gastric Ulcer, and Duodenal Ulcer
• Interventions: Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole

• Registration Number: NCT01922765
• Lead Sponsor: The Catholic University of Korea

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-09
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• patients infected with Helicobacter pylori

Exclusion Criteria

• cancer
• pregnancy
• formerly treated with eradication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOC group	amoxicillin, clarithromycin, metronidazole, rabeprazole	AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
AOM group	amoxicillin, clarithromycin, metronidazole, rabeprazole	AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
Sequential group	amoxicillin, clarithromycin, metronidazole, rabeprazole	Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
concomitant group	amoxicillin, clarithromycin, metronidazole, rabeprazole	concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori	6 months (Feb 2014)	measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment

Trial Locations

Locations (1)

Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of