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

Phase 4

• Conditions: Ulcer
• Interventions: Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin; Drug: Lansoprazole (proton pump inhibitor), placebo

• Registration Number: NCT00926809
• Lead Sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Last Update Submitted: 2009-06-24
• Last Update Posted: 2009-06-25
• Primary Completion: 2010-09
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eradication	Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin	Helicobacter pylori eradication
No eradication	Lansoprazole (proton pump inhibitor), placebo	No eradication for Helicobacter pylori

Primary Outcome Measures

Name	Time	Method
ulcer healing rate by endoscopic assessment	8 weeks

Secondary Outcome Measures

Name	Time	Method
ulcer reduction rate by endoscopic assessment	8 weeks

Trial Locations

Locations (6)

National Cancer Center Korea; 🇰🇷 Goyang, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of