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

Not Applicable

Recruiting

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0008624
• Lead Sponsor: Kyungpook National University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of 7 days fexuprazan based triple therapy for H. pylori eradication

Secondary Outcome Measures

Name	Time	Method
The effect of H. pylori eradication based on antibiotic resistance