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

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ClinicalTrials.gov Identifier: NCT00926809
Recruitment Status : Unknown
Verified June 2009 by Korean College of Helicobacter and Upper Gastrointestinal Research.
Recruitment status was:  Recruiting
First Posted : June 24, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Korean College of Helicobacter and Upper Gastrointestinal Research

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. ulcer healing rate by endoscopic assessment [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. ulcer reduction rate by endoscopic assessment [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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         
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         
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joo Young Cho         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Chan Lee         
Sub-Investigator: Jae Hee Cheon         
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

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
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents