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

Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00926809
• Other study ID #: 2009KHR001
• Status: Recruiting
• Phase: Phase 4
• First received: June 23, 2009
• Last updated: June 24, 2009
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Korean College of Helicobacter and Upper Gastrointestinal Research
• Contact: Ho June Song, Ph.D
• Phone: 82-2-3010-3916
• Email: hojunesong[@]yahoo.co.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Ulcer
• Ulcer

Intervention

Drug:
• Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
• Lansoprazole (proton pump inhibitor), placebo
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean College of Helicobacter and Upper Gastrointestinal Research

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ulcer healing rate by endoscopic assessment		8 weeks	No
Secondary	ulcer reduction rate by endoscopic assessment		8 weeks	No