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

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ClinicalTrials.gov Identifier: NCT01167101
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Stomach Ulcer Drug: Rebamipide Drug: pantoprazole

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
Study Start Date : May 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Pantoprazole
controls Pantoprazole 40mg qd 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


Outcome Measures

Primary Outcome Measures :
  1. Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer [ Time Frame: at 2month after endoscopic submucosal dissection (ESD) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01167101


Locations
Korea, Republic of
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Sponsors and Collaborators
Kangdong Sacred Heart Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shin, Woon Geon, Professor, Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01167101     History of Changes
Other Study ID Numbers: 08-62
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

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

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