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

This study is currently recruiting participants.

Verified by Korean College of Helicobacter and Upper Gastrointestinal Research, June 2009

First Received: June 23, 2009 Last Updated: June 24, 2009 History of Changes

Sponsor:	Korean College of Helicobacter and Upper Gastrointestinal Research
Information provided by:	Korean College of Helicobacter and Upper Gastrointestinal Research
ClinicalTrials.gov Identifier:	NCT00926809

Purpose

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.

Condition	Intervention	Phase
Ulcer	Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin Drug: Lansoprazole (proton pump inhibitor), placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Lansoprazole

U.S. FDA Resources

Further study details as provided by Korean College of Helicobacter and Upper Gastrointestinal Research:

Primary Outcome Measures:

ulcer healing rate by endoscopic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ulcer reduction rate by endoscopic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	232
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Eradication: Active Comparator Helicobacter pylori eradication	Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
No eradication: Placebo Comparator No eradication for Helicobacter pylori	Drug: Lansoprazole (proton pump inhibitor), placebo Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926809

Contacts

Contact: Ho June Song, Ph.D

82-2-3010-3916

hojunesong@yahoo.co.kr

Locations

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

Sponsors and Collaborators

Korean College of Helicobacter and Upper Gastrointestinal Research

Investigators

Principal Investigator:

Hyun Chae Jung

Korean College of Helicobacter and Upper Gastrointestinal Research

More Information

No publications provided

Responsible Party:	Korean College of Helicobacter and Upper Gastrointestinal Research ( Ho June Song )
Study ID Numbers:	2009KHR001
Study First Received:	June 23, 2009
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00926809 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korean College of Helicobacter and Upper Gastrointestinal Research:

endoscopic mucosal resection
iatrogenic

Additional relevant MeSH terms:

Stomach Ulcer
Anti-Infective Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Protein Synthesis Inhibitors

Clarithromycin
Anti-Bacterial Agents
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Lansoprazole
Peptic Ulcer

ClinicalTrials.gov processed this record on February 04, 2010