A Prospective, Multi-Center, Pilot study to Evaluate the Efficacy and Safety of Fexuprazan based 7 days triple therapy for Eradication of Helicobacter pylori Infections

Kyungpook National University Medical Center0 个研究点目标入组 50 人开始时间: 待定最近更新: 2023年8月1日

试验速览

暂无简介。

•1. The patients age 20~80 years old
•2. The participants who confirmed H. pylori infection by 2 of methods as following: RUT, histology, serology (HP IgG)
•3. The participants who understand the protocol of current clinical trial.
•4. The participants who diagnosed atrophic gastritis, peptic ulcer, gastric MALToma, functional dyspepsia, idopathic thrombocytopenic purpora, underwent endoscopic rerection who diagnosed early gastric cancer or gastric adenoma, or family history of gastric cancer
•5. The participants who agreed to participate clinical trial.
•6. The participants who agreed with the contraception for this clinical trial

•1. The participants who have a history of allergic reaction to the study drugs
•2. The participants who have
•3. The participants who have abnormal serology results
•- upper 2 folds level of AST, ALT, ALP, r-GT, total bilirubin
•- upper 1.5 folds level of BUN, creatinine
•4. those using PPIs, PCAB, H2 blockers, antacids, bismuth-containing drugs, or antibiotics within 14–28 days before screening
•5. those who showed abnormal EKG
•6. those who have CNS disease or electrolyte abnormality
•7. those who pregnant or lactating women;
•8. those who have uncontrolled DM, HTN or liver cirrhosis
•9. those with a history of alcohol abuse or drug addiction
•10. those who have gastrointestinal malignancy except receiving endoscopic resection
•11. those with a history of gastrectomy or esophagectomy
•12. those who have intolerance of galactose, lactose and malabsorption patients
•13. those who have current gastrointestinal bleeding
•14. a history of H. pylori eradication
•15. those who participate other clinical trial within 30 days
•17. The participants who can not underlying clinical trial determined by investigator.

发起方