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Concomitant Therapy of H. Pylori

Primary Purpose

Gastritis, Gastric Ulcer, and Duodenal Ulcer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
amoxicillin, clarithromycin, metronidazole, rabeprazole
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis, Gastric Ulcer, and Duodenal Ulcer focused on measuring Helicobacter, Eradication

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients infected with Helicobacter pylori

Exclusion Criteria:

  • cancer
  • pregnancy
  • formerly treated with eradication

Sites / Locations

  • Yeouido St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AOC group

AOM group

Sequential group

concomitant group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 12, 2013
Last Updated
February 9, 2014
Sponsor
The Catholic University of Korea
Collaborators
Bucheon St. Mary's Hospital, St Vincent's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01922765
Brief Title
Concomitant Therapy of H. Pylori
Official Title
Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Bucheon St. Mary's Hospital, St Vincent's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis, Gastric Ulcer, and Duodenal Ulcer
Keywords
Helicobacter, Eradication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AOC group
Arm Type
Experimental
Arm Description
AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
Arm Title
AOM group
Arm Type
Experimental
Arm Description
AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
Arm Title
Sequential group
Arm Type
Experimental
Arm Description
Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
Arm Title
concomitant group
Arm Type
Experimental
Arm Description
concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin, clarithromycin, metronidazole, rabeprazole
Other Intervention Name(s)
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
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
Description
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
Time Frame
6 months (Feb 2014)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients infected with Helicobacter pylori Exclusion Criteria: cancer pregnancy formerly treated with eradication
Facility Information:
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Il Kim, MD,PhD
Phone
82-10-6345-9977
Email
jikim@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin Il Kim, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25574111
Citation
Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015 Jan 7;21(1):351-9. doi: 10.3748/wjg.v21.i1.351.
Results Reference
derived

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Concomitant Therapy of H. Pylori

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