None listed
Conditions
Interventions
Drug : administration method
-Once daily in the morning before meals orally administered in the same way as the test group and the control group
- test group
Fexuprazan 40mg
-control group
Rabeprazole 20mg
administration period
: From Day 1 to Day 28, 1st upper gastrointestinal endoscopy performed after administration for 4 weeks
- when the ulcer is cured
discontinuation
-If ulcers remain
Additional administration for 4 weeks from Day 29 to Day 56
Sponsors
The Catholic University of Korea, Daejeon St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peptic ulcer healing rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the size of the ulcer | — |
Countries
Korea, Republic of
Contacts
Public ContactJu Seok Kim
CHUNGNAM NATIONAL UNIVERSITY SEJONG HOSPITAL
Outcome results
None listed