Trial | NCT00926809  Report issue

Title

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

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    Ulcer

  • Study Participants

    232
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.
Study Started
Sep 30
2008
Primary Completion
Sep 30
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Jun 25
2009
Estimate

Drug Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg

Drug Lansoprazole (proton pump inhibitor), placebo

Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Eradication Active Comparator

Helicobacter pylori eradication

No eradication Placebo Comparator

No eradication for Helicobacter pylori

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
No Results Posted