Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
ulcer healing rate by endoscopic assessment
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Hyun Chae Jung
Investigator Role:
Principal Investigator
Investigator Affiliation:
Korean College of Helicobacter and Upper Gastrointestinal Research
Authority:
Korea: Food and Drug Administration
Study ID:
2009KHR001
NCT ID:
NCT00926809
Start Date:
September 2008
Completion Date:
December 2010
Related Keywords:
- Ulcer
- endoscopic mucosal resection
- iatrogenic
- Stomach Ulcer
- Ulcer