search
Back to results

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

Primary Purpose

Ulcer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Lansoprazole (proton pump inhibitor), placebo
Sponsored by
Korean College of Helicobacter and Upper Gastrointestinal Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcer focused on measuring endoscopic mucosal resection, iatrogenic

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center KoreaRecruiting
  • Asan Medical CenterRecruiting
  • Korea University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Soonchunhyang University HospitalRecruiting
  • Yonsei University Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Eradication

No eradication

Arm Description

Helicobacter pylori eradication

No eradication for Helicobacter pylori

Outcomes

Primary Outcome Measures

ulcer healing rate by endoscopic assessment

Secondary Outcome Measures

ulcer reduction rate by endoscopic assessment

Full Information

First Posted
June 23, 2009
Last Updated
June 24, 2009
Sponsor
Korean College of Helicobacter and Upper Gastrointestinal Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00926809
Brief Title
H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korean College of Helicobacter and Upper Gastrointestinal Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer
Keywords
endoscopic mucosal resection, iatrogenic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eradication
Arm Type
Active Comparator
Arm Description
Helicobacter pylori eradication
Arm Title
No eradication
Arm Type
Placebo Comparator
Arm Description
No eradication for Helicobacter pylori
Intervention Type
Drug
Intervention Name(s)
Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Intervention Description
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
Intervention Type
Drug
Intervention Name(s)
Lansoprazole (proton pump inhibitor), placebo
Intervention Description
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo
Primary Outcome Measure Information:
Title
ulcer healing rate by endoscopic assessment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
ulcer reduction rate by endoscopic assessment
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho June Song, Ph.D
Phone
82-2-3010-3916
Email
hojunesong@yahoo.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Chae Jung
Organizational Affiliation
Korean College of Helicobacter and Upper Gastrointestinal Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho June Song
Email
hjsong@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Hwoon-Yong Jung
Facility Name
Korea University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoon Jae Chun
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Gyun Kim
First Name & Middle Initial & Last Name & Degree
Hyun Chae Jung
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Young Cho
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Chan Lee
First Name & Middle Initial & Last Name & Degree
Jae Hee Cheon

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs