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15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

NCT01887249 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2013-08-13

No results posted yet for this study

Summary

10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Clarithromycin

DRUG

metronidazole

DRUG

esomeprazole

Sponsors & Collaborators

  • Ministry of Education, Republic of Korea (2012R1A1A3A04002680)

    collaborator UNKNOWN

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887249 on ClinicalTrials.gov