H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection

NCT ID: NCT00926809

Last Updated: 2009-06-25

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

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.

Detailed Description

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Conditions

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Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eradication

Helicobacter pylori eradication

Group Type ACTIVE_COMPARATOR

Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

Intervention Type DRUG

Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg

No eradication

No eradication for Helicobacter pylori

Group Type PLACEBO_COMPARATOR

Lansoprazole (proton pump inhibitor), placebo

Intervention Type DRUG

Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Interventions

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Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg

Intervention Type DRUG

Lansoprazole (proton pump inhibitor), placebo

Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 30 - 75 years old
* Early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size)
* Helicobacter pylori positive

Exclusion Criteria

* Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
* History of Helicobacter pylori eradication
* History of gastric surgery or other cancers
* Major comorbidities
* Medication of ASA, NSAIDS, steroids, anti-coagulants
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean College of Helicobacter and Upper Gastrointestinal Research

OTHER

Sponsor Role lead

Responsible Party

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Korean College of Helicobacter and Upper Gastrointestinal Research

Principal Investigators

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Hyun Chae Jung

Role: PRINCIPAL_INVESTIGATOR

Korean College of Helicobacter and Upper Gastrointestinal Research

Locations

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National Cancer Center Korea

Goyang, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Korea University Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Yonsei University Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ho June Song, Ph.D

Role: CONTACT

82-2-3010-3916

Facility Contacts

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Il Ju Choi

Role: primary

Ho June Song

Role: primary

Hoon Jae Chun

Role: primary

Sang Gyun Kim

Role: primary

Joo Young Cho

Role: primary

Yong Chan Lee

Role: primary

Other Identifiers

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2009KHR001

Identifier Type: -

Identifier Source: org_study_id

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