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

June 24, 2009 updated by: Korean College of Helicobacter and Upper Gastrointestinal Research

Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

232

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang, Korea, Republic of
        • Recruiting
        • National Cancer Center Korea
        • Contact:
          • Il Ju Choi
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Sub-Investigator:
          • Hwoon-Yong Jung
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Sang Gyun Kim
        • Principal Investigator:
          • Hyun Chae Jung
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Hospital
        • Contact:
          • Hoon Jae Chun
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
          • Joo Young Cho
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:
          • Yong Chan Lee
        • Sub-Investigator:
          • Jae Hee Cheon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eradication
Helicobacter pylori eradication
Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
Placebo Comparator: No eradication
No eradication for Helicobacter pylori
Drug: Lansoprazole (proton pump inhibitor), placebo
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ulcer healing rate by endoscopic assessment
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ulcer reduction rate by endoscopic assessment
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean College of Helicobacter and Upper Gastrointestinal Research

Investigators

  • Principal Investigator: Hyun Chae Jung, Korean College of Helicobacter and Upper Gastrointestinal Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009KHR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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