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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008624

Enrollment

Registered

2023-07-17

Start date

2023-05-11

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Administration 7 days fexuprazan based triple therapy (Fexufrazan 40 mg, Amoxicillin 1,000 mg, Clarithromycin 500 mg, b.i.d., per oral for 7 days) in H. pylori infected patients

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The efficacy of 7 days fexuprazan based triple therapy for H. pylori eradication	—

Secondary

Measure	Time frame
The effect of H. pylori eradication based on antibiotic resistance	—

Countries

Korea, Republic of

Contacts

Public ContactYong Hwan Kwon

Kyungpook National University Medical Center

tear9754006@yahoo.co.kr+82-53-200-3077

Outcome results