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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926809

Enrollment

232

Registered

2009-06-24

Start date

2008-09-30

Completion date

2010-12-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcer

Keywords

endoscopic mucosal resection, iatrogenic

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.

Interventions

DRUGLansoprazole (proton pump inhibitor), amoxicillin, clarythromycin

Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg

DRUGLansoprazole (proton pump inhibitor), placebo

Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ulcer healing rate by endoscopic assessment	8 weeks

Secondary

Measure	Time frame
ulcer reduction rate by endoscopic assessment	8 weeks

Countries

South Korea

Contacts

Primary ContactHo June Song, Ph.D

hojunesong@yahoo.co.kr82-2-3010-3916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026