Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
Primary Purpose
Stomach Ulcer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rebamipide
pantoprazole
Sponsored by

About this trial
This is an interventional treatment trial for Stomach Ulcer focused on measuring Rebamipide, gastric ulcer, healing rate, iatrogenic gastric ulcer after endoscopic submucosal dissection
Eligibility 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
Sites / Locations
- Kangdong Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Pantoprazole
Pantoprazole + Rebamipde
Arm Description
controls Pantoprazole 40mg qd for 28days
Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
Outcomes
Primary Outcome Measures
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01167101
First Posted
July 20, 2010
Last Updated
September 3, 2015
Sponsor
Kangdong Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01167101
Brief Title
Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
Official Title
Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangdong Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer
Keywords
Rebamipide, gastric ulcer, healing rate, iatrogenic gastric ulcer after endoscopic submucosal dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pantoprazole
Arm Type
Other
Arm Description
controls Pantoprazole 40mg qd for 28days
Arm Title
Pantoprazole + Rebamipde
Arm Type
Active Comparator
Arm Description
Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Intervention Description
Rebamipide 100mg Tid for 28days
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Intervention Description
pantoprazole 40mg qd for 28days
Primary Outcome Measure Information:
Title
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
Description
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.
Time Frame
at 2month after endoscopic submucosal dissection (ESD)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22281110
Citation
Shin WG, Kim SJ, Choi MH, Kim KO, Jang HJ, Park CH, Baek IH, Kim KH, Baik GH, Kae SH, Kim JH, Kim HY. Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.
Results Reference
derived
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Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
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