Concomitant Therapy of H. Pylori

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT01922765

Collaborator

Bucheon St. Mary's Hospital (Other), St. Vincent's Hospital-Manhattan (Other)

540

Enrollment

Location

Arms

Duration (Months)

89.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastritis, Gastric Ulcer, and Duodenal Ulcer	Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole	Phase 4

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

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AOC group AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days	Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole Other Names: 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
Experimental: AOM group AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days	Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole Other Names: 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
Experimental: Sequential group Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days	Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole Other Names: 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
Experimental: concomitant group concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days	Drug: amoxicillin, clarithromycin, metronidazole, rabeprazole Other Names: 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

Outcome Measures

Primary Outcome Measures

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