H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection
Information source: Korean College of Helicobacter and Upper Gastrointestinal Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcer
Intervention: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin (Drug); Lansoprazole (proton pump inhibitor), placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korean College of Helicobacter and Upper Gastrointestinal Research Official(s) and/or principal investigator(s):
Hyun Chae Jung, Principal Investigator, Affiliation: Korean College of Helicobacter and Upper Gastrointestinal Research
Overall contact:
Ho June Song, Ph.D, Phone: 82-2-3010-3916, Email: hojunesong@yahoo.co.kr
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: ulcer healing rate by endoscopic assessment
Secondary outcome: ulcer reduction rate by endoscopic assessment
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Ho June Song, Ph.D, Phone: 82-2-3010-3916, Email: hojunesong@yahoo.co.kr
Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting
Sang Gyun Kim
Hyun Chae Jung, Principal Investigator
Asan Medical Center, Seoul, Korea, Republic of; Recruiting
Ho June Song, Email: hjsong@amc.seoul.kr
Hwoon-Yong Jung, Sub-Investigator
Yonsei University Severance Hospital, Seoul, Korea, Republic of; Recruiting
Yong Chan Lee
Jae Hee Cheon, Sub-Investigator
Soonchunhyang University Hospital, Seoul, Korea, Republic of; Recruiting
Joo Young Cho
Korea University Hospital, Seoul, Korea, Republic of; Recruiting
Hoon Jae Chun
National Cancer Center Korea, Goyang, Korea, Republic of; Recruiting
Il Ju Choi
Additional Information
Starting date: September 2008
Ending date: December 2010
Last updated: June 24, 2009
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