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Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kangdong Sacred Heart Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01167101
First received: July 20, 2010
Last updated: July 22, 2010
Last verified: May 2010
History of Changes
  Purpose

Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.


Condition Intervention
Stomach Ulcer
 Drug: Rebamipide
Drug: pantoprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Kangdong Sacred Heart Hospital:

Primary Outcome Measures:
  • Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer [ Time Frame: at 2month after endoscopic submucosal dissection (ESD) ] [ Designated as safety issue: No ]
    Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.


Estimated Enrollment: 310
Study Start Date: May 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pantoprazole
controls Pantoprazole 40mg qd for 28days
 Drug: Rebamipide
Rebamipide 100mg Tid for 28days
Drug: pantoprazole
pantoprazole 40mg qd for 28days
Active Comparator: Pantoprazole + Rebamipde
Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
 Drug: Rebamipide
Rebamipide 100mg Tid for 28days
Drug: pantoprazole
pantoprazole 40mg qd for 28days

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients underwent ESD for gastric adenoma or cancer

Exclusion Criteria:

  • subjects with previous gastric surgery
  • subjects taking aspirin, anticoagulant, or antiplatelet agent
  • subjects having malignancy except gastric cancer
  • pregnant or breast-feeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167101

Contacts
Contact: Woon Geon Shin, MD 82-2-2225-2814 sgun91@medimail.co.kr

Locations
Korea, Republic of
Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 134-701
Contact: Woon Geon Shin, MD     82-2-2224-2814     sgun91@medimail.co.kr    
Principal Investigator: Woon Geon Shin, MD            
Sponsors and Collaborators
Kangdong Sacred Heart Hospital
  More Information

No publications provided by Kangdong Sacred Heart Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shin, Woon Geon/ assistant professor, Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01167101     History of Changes
Other Study ID Numbers: 08-62
Study First Received: July 20, 2010
Last Updated: July 22, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Kangdong Sacred Heart Hospital:
Rebamipide
gastric ulcer
healing rate
iatrogenic gastric ulcer after endoscopic submucosal dissection

Additional relevant MeSH terms:
Stomach Diseases
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Rebamipide
Pantoprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013