Concomitant Therapy of H. Pylori

February 9, 2014 updated by: Jin Il Kim, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-713
        • Recruiting
        • Yeouido St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Jin Il Kim, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients infected with Helicobacter pylori

Exclusion Criteria:

  • cancer
  • pregnancy
  • formerly treated with eradication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months (Feb 2014)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

St Vincent's Hospital
Bucheon St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 9, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • concomitant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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