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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Korean College of Helicobacter and Upper Gastrointestinal Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korean College of Helicobacter and Upper Gastrointestinal Research
ClinicalTrials.gov Identifier:
NCT00926809
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Ulcer
Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Drug: Lansoprazole (proton pump inhibitor), placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Korean College of Helicobacter and Upper Gastrointestinal Research:

Primary Outcome Measures:
  • ulcer healing rate by endoscopic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ulcer reduction rate by endoscopic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eradication
Helicobacter pylori eradication
Drug: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin
Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
Placebo Comparator: No eradication
No eradication for Helicobacter pylori
Drug: Lansoprazole (proton pump inhibitor), placebo
Lansoprazole, Amoxicillin placebo, Clarythromycin placebo

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926809

Contacts
Contact: Ho June Song, Ph.D 82-2-3010-3916 hojunesong@yahoo.co.kr

Locations
Korea, Republic of
National Cancer Center Korea Recruiting
Goyang, Korea, Republic of
Contact: Il Ju Choi         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ho June Song       hjsong@amc.seoul.kr   
Sub-Investigator: Hwoon-Yong Jung         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Chan Lee         
Sub-Investigator: Jae Hee Cheon         
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joo Young Cho         
Korea University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hoon Jae Chun         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang Gyun Kim         
Principal Investigator: Hyun Chae Jung         
Sponsors and Collaborators
Korean College of Helicobacter and Upper Gastrointestinal Research
Investigators
Principal Investigator: Hyun Chae Jung Korean College of Helicobacter and Upper Gastrointestinal Research
  More Information

No publications provided

Responsible Party: Ho June Song, Korean College of Helicobacter and Upper Gastrointestinal Research
ClinicalTrials.gov Identifier: NCT00926809     History of Changes
Other Study ID Numbers: 2009KHR001
Study First Received: June 23, 2009
Last Updated: June 24, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean College of Helicobacter and Upper Gastrointestinal Research:
endoscopic mucosal resection
iatrogenic

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014