Effect of Pexuprazan on the treatment of gastric ulcer that occurs after endoscopic submucosal dissection:Multicenter, Double Blindness, Randomized Study
- Conditions
- Neoplasms
- Registration Number
- KCT0009356
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 118
?Men or women between the ages of 19 and 80.
?Patients who are undergoing endoscopic submucosal dissection for gastric adenoma or early gastric cancer, and the intestinal diameter of the resected tissue is 2 cm or more.
?Patients who agree to participate in this study and voluntarily sign a written informed consent form.
?Hypersensitivity or history of hypersensitivity to any component of the investigational drug or to benzimidazoles.
?Patients taking or planning to take drugs related to the treatment of gastroesophageal reflux disease (P-cab, PPI, H2 receptor antagonists, prostaglandins, gastric mucosal protective agents, gastrointestinal motility promoters) within the last 2 weeks.
?Patients with any of the following abnormal laboratory tests
A. Total Bilirubin, Creatinine > 1.5 times the upper limit of institutional normality
B. AST, ALT, Alkaline phosphatase, BUN > 2 times the upper limit of institutional normality
? History of diagnosis of cancer other than gastric cancer within 5 years
Patients with a history of the following diseases (Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal dysmotility, esophageal stricture, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease)
? Patients who have undergone major surgery that may affect gastric acid secretion.
Patients who are unable to undergo upper gastrointestinal endoscopy (esophageal disease, gastrointestinal bleeding, etc.)
Those who are contraindicated for endoscopic submucosal resection (thrombocytopenia, coagulation disorders, etc.)
Patients who cannot stop the following medications (warfarin, clopidogrel, direct oral anticoagulant, steroid, NSAIDs drug anticholinergics, prostaglandin analogs, sucralfate, aspirin) until the end of the study (for 8 weeks).
Patients receiving atazanavir, nelfinavir, or rilpivirine-containing agents.
Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
? Subjects with severe organ failure (hepatic or renal insufficiency, etc.).
? Pregnant and lactating women
? Subjects who do not agree to use adequate contraception for themselves or their partner for the duration of the study.
However, women who are medically unable to become pregnant may participate in this study: menopausal (amenorrhea for more than 24 months), women who have undergone hysterectomy, salpingo-oophorectomy, bilateral oophorectomy, etc.
? Participation in another clinical trial within 30 days prior to screening
? Other patients deemed unsuitable for participation in this study by the investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of ulcer scars identified by upper gastrointestinal endoscopy after treatment with study drug (fexuprazan) versus control drug (esomeprazole)
- Secondary Outcome Measures
Name Time Method Percentage of ulcer reduction confirmed by upper GI endoscopy