Comparison of effects of Tegoprazan and Mucosta combination therapy and Tegoprazan monotherapy on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding for iatrogenic ulcers after Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer: A Multicenter, Randomized, Parallel and Prospective study.

Kangdong Sacred Heart Hospital0 个研究点目标入组 140 人开始时间: 待定最近更新: 2022年4月4日

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•? Male or female subjects =19 and <85 years of age
•? Patients undergoing endoscopic submucosal dissection for gastric adenoma or early gastric cancer with a resected tissue having a length of at least 2 cm
•? Patients who agreed to participate in the study and voluntarily signed a written informed consent form

•? Hypersensitivity to the IMP
•? Use of prohibited drugs (such as atazanavir) for combination with the IMP
•? Laboratory abnormalities, as listed below
•- Total bilirubin or creatinine >1.5x institutional upper limit of normal (ULN)
•- AST, ALT, alkaline phosphatase, BUN >2x institutional ULN
•? Diagnosis of cancer other than gastric cancer in the last 5 years
•? History of the following diseases: Zollinger-Ellison syndrome, Barrett' s esophagus, primary esophageal motility disorder, esophageal stenosis, pancreatitis, malabsorption, or severe cardiovascular or pulmonary disease
•? Patients who have undergone a major surgery that may affect gastric acid secretion
•? Patients who are unable to discontinue the following drugs until the end of the study (for 8 weeks): warfarin, clopidogrel, direct oral anticoagulant, steroid, NSAIDs drug anticholinergics, prostaglandin analogs, sucralfate, and aspirin
•? Serious organ failure (such as hepatic or renal dysfunction)
•? Pregnant or breastfeeding women
•? Experience of participating in other clinical trials within 30 days prior to screening
•? Other patients that the investigator considers ineligible for this study

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