The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritis patients who have undergone endoscopic resection of early gastric cancer
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007907
- Lead Sponsor
- Kyungpook National University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 240
Gastritis subjects who have undergone the ESD/EMR operation due to early stage gastric cancer
1. Male/Female patients age 20 to 65 at the time of writing an informed consent.
2. Subjects who have consented to participate in this study by signing an informed form.
1. Patients with known hypersensitivity to Rebamipide formulation.
2. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception.
3. History of psychological disorder, alcoholics, and drug abuser.
4. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.
5. Patients who previously underwent another clinical trial within 4 weeks
6. Patients administrated with any drugs that can affect the efficacy of study regimen within 2 weeks, prior to enrolment and/or those who are required of aspirin, NSAIDs, anti-coagulants, prostaglandin E, corticosteroids during the study periods.
7. Patients administrated with any other gastro-protective drugs that can affect the efficacy of Rebamipide during the study period.
8. Other concurrent organic gastric disease in endoscopy(i.e., peptic ulcer disease, other malignancies)
9. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
10. Patients with negative H. pylori infection as a result of eradication therapy before screening.
11. Patients who failed HP eradication therapy on baseline UBT
12. Patients who have history of gastrectomy for any reason
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is to evaluate the difference in the effect of between rebamipide and placebo on regression of gastric atrophy and intestinal metaplasia.
- Secondary Outcome Measures
Name Time Method To evaluate the effect of IP drugs after discontinuation on regression of atrophy and metaplasia. To compare the rate of MGN in more than 4 year follow up period between groups.