The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritispatients who have undergone endoscopic resection of early gastric cancer: multicenter, randomized, double blinded, placebo controlled trial

Kyungpook National University Medical Center0 个研究点目标入组 240 人开始时间: 待定最近更新: 2022年11月28日

试验速览

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•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

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