Concomitant Therapy of H. Pylori

NCT ID: NCT01922765

Last Updated: 2014-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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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

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* 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

Conditions

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Gastritis, Gastric Ulcer, and Duodenal Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AOC group

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

Group Type EXPERIMENTAL

amoxicillin, clarithromycin, metronidazole, rabeprazole

Intervention Type DRUG

AOM group

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

Group Type EXPERIMENTAL

amoxicillin, clarithromycin, metronidazole, rabeprazole

Intervention Type DRUG

Sequential group

Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days

Group Type EXPERIMENTAL

amoxicillin, clarithromycin, metronidazole, rabeprazole

Intervention Type DRUG

concomitant group

concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Group Type EXPERIMENTAL

amoxicillin, clarithromycin, metronidazole, rabeprazole

Intervention Type DRUG

Interventions

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amoxicillin, clarithromycin, metronidazole, rabeprazole

Intervention Type DRUG

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* patients infected with Helicobacter pylori

Exclusion Criteria

* cancer
* pregnancy
* formerly treated with eradication
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bucheon St. Mary's Hospital

OTHER

Sponsor Role collaborator

St Vincent's Hospital

OTHER

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jin Il Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jin Il Kim, MD,PhD

Role: primary

82-10-6345-9977

References

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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.

Reference Type DERIVED
PMID: 25574111 (View on PubMed)

Other Identifiers

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concomitant

Identifier Type: -

Identifier Source: org_study_id

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