KCT0008647尚未招募Unknown
The Comparison of Fexuclue (Fexuprazan) and Rabeprazole for Treatment of Peptic Ulcer: A Multicenter, Randomized, open Study
The Catholic University of Korea, Daejeon St. Mary's Hospital0 个研究点目标入组 106 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. A person aged between 20 and 75 years of age as of the date of obtaining consent
- •2. Cases diagnosed as peptic ulcer (gastric ulcer, duodenal ulcer) by upper gastrointestinal endoscopy
- •3. Ulcer is A1 or A2 stage on Sakita-Miwa classification, an endoscopic classification method
- •4. The size of the ulcer is 0.5-3.0cm
- •5. A person who voluntarily decided to participate and gave written consent to the consent form for clinical trial subjects
- •6. A person who can use a medically reasonable method of contraception during the clinical trial period
- •-Medically valid contraceptive methods: intrauterine device (loop, Mirena), physical barrier method (male condom, female condom (Femidom)), subcutaneous contraceptive method (Implanon, etc.), long-acting contraceptive injection, or tubal resection and ligation, vasectomy, etc. (only Oral contraceptives cannot be used during this clinical trial, and it is recommended to use double contraception to prevent pregnancy during participation in this trial.)
排除标准
- •1. Subjects with gastrointestinal bleeding, perforation, esophageal stricture, ulcer stricture, pyloric stricture, esophagogastric varices, long segment Barrett's esophagus (LSBE) greater than 3 cm, or malignant tumors confirmed by upper gastrointestinal endoscopy performed at screening
- •2. Those who have undergone major surgery that may affect gastric acid secretion in the past, such as upper gastrointestinal resection or gastric acid secretion suppression. However, simple perforation, appendectomy, cholecystectomy, and laparoscopic benign tumor resection are excluded.
- •3. Zollinger-Ellison Syndrome
- •4. In case of contraindications to administration among the approvals of fexuprazan and rabeprazole, such as hypersensitivity to the components of fexuprazan or rabeprazole and a history thereof (refer to the approvals in the text)
- •5. Pregnant or lactating women
- •6. Those with uncontrolled cardiopulmonary disease, renal disease, liver disease, endocrine disease, cranial nerve disease, or thrombotic disease (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.)
- •7. When it is difficult to conduct proper research due to cognitive impairment, intellectual disability, mental illness, etc.
- •8. Acid secretion inhibitors [H2 receptor antagonist, proton pump inhibitor (PPI), potassium competitive acid secretion inhibitor (P-CAB)], antacids, gastric mucosal protective agents (prostaglandin preparations, mucosal blood flow promoters), glucocorticosteroids within 2 weeks of randomization In case of taking steroids (but topical administration is allowed)
- •9. In case of taking antiplatelet or anticoagulant within 1 week of randomization
- •10. In case of continuous use of glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and other antiplatelet agents, anticoagulants, and concomitantly contraindicated drugs during the clinical trial period
- •11. AST, ALT, ALP, GGT, total bilirubin level is more than twice the upper limit reference value, or creatinine level is more than twice the upper limit reference value
- •12. Those with a history of malignant tumor within the last 5 years
- •-If you have a history of gastrointestinal malignant tumor, you cannot participate in this study regardless of the period.
- •- Those who have been diagnosed with complete remission (CR) of malignant tumors other than the gastrointestinal tract and have passed more than 5 years without recurrence from the date of judgment can be included.
- •13. Thrombocytopenia or dysfunction (=20,000 /µL)
- •14. Those with clinically significant abnormal ECG
- •15. Those who cannot perform upper gastrointestinal endoscopy (esophageal surgery, esophageal stricture, noncooperation, etc.)
- •16. Those who have been treated for H.pylori eradication within 4 weeks of screening
- •17. In addition, those who have clinically significant findings that are considered inappropriate for this test based on medical judgment by the investigator
研究者
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