Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial

NCT ID: NCT01418300

Last Updated: 2015-04-28

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

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to improve first line Helicobacter pylori eradication rate and to compare the sequential versus conventional triple therapy.

Detailed Description

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Conditions

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Helicobacter Infected Patients

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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sequential therapy

first five day amoxicillin+PPI later five day PPI+clarithromycin+metronidazole

Group Type ACTIVE_COMPARATOR

sequential versus triple

Intervention Type DRUG

sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid

conventional triple thearpy

PPI+amoxicillin+clarithromycin

Group Type ACTIVE_COMPARATOR

sequential versus triple

Intervention Type DRUG

sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid

Interventions

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sequential versus triple

sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* peptic ulcer diseae
* two test positive rapid urease test, culture, histology

Exclusion Criteria

* lactating or pregnant
* previous stomach surgery
* severe underlying disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun-Won Chung

INDUSTRY

Sponsor Role lead

Responsible Party

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Jun-Won Chung

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GMC2010-088

Identifier Type: -

Identifier Source: org_study_id

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