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
1 other identifier
interventional
232
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2008
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 25, 2009
June 1, 2009
2 years
June 23, 2009
June 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ulcer healing rate by endoscopic assessment
8 weeks
Secondary Outcomes (1)
ulcer reduction rate by endoscopic assessment
8 weeks
Study Arms (2)
Eradication
ACTIVE COMPARATORHelicobacter pylori eradication
No eradication
PLACEBO COMPARATORNo eradication for Helicobacter pylori
Interventions
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo
Eligibility Criteria
You may qualify if:
- years old
- Early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size)
- Helicobacter pylori positive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
National Cancer Center Korea
Goyang, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Chae Jung
Korean College of Helicobacter and Upper Gastrointestinal Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
December 1, 2010
Last Updated
June 25, 2009
Record last verified: 2009-06