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15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

NCT ID: NCT01887249

Last Updated: 2013-08-13

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

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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15 day sequential eradication therapy

the 15-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for 10 days.

Group Type EXPERIMENTAL

Clarithromycin

Intervention Type DRUG

metronidazole

Intervention Type DRUG

esomeprazole

Intervention Type DRUG

10-day sequential eradication therapy

the 10-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five days

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

metronidazole

Intervention Type DRUG

esomeprazole

Intervention Type DRUG

7-day PPI triple eradication therapy

7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clarithromycin

Intervention Type DRUG

metronidazole

Intervention Type DRUG

esomeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with H. pylori infection who had never received treatment for H. pylori infection
* H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Education, Republic of Korea (2012R1A1A3A04002680)

UNKNOWN

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

Professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1007/106-001

Identifier Type: -

Identifier Source: org_study_id