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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


Phase 4
30 Years
75 Years
Open (Enrolling)
Both
Ulcer

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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

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