The efficacy and safety of Fexuprazan-based triple therapy for Helicobacter pylori eradication

The efficacy and safety of Fexuprazan-based triple therapy compared with a PPI-based triple therapy for Helicobacter pylori eradication

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008525

Enrollment

Registered

2023-06-15

Start date

2023-04-26

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Drug : Coparison of Fexuprazan based therapy (fexuprazan 40mg, amoxicillin 1000mg, clarithromycin 500mg twice daily for 7 days) with rabeprazole based therapy (rabeprazole 20mg, amoxicillin 1000mg, cl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with atrophic gastritis, peptic ulcer disease, low grade MALT lymphoma, functional dyspepsia, idiopathic thrombotic purpura, gastric cancer or gastric adenoma diagnosed after endoscopic resection, family history of gastric cancer who tested positive for Helicobacter pylori using rapid urease test and urea breath test

Exclusion criteria

Exclusion criteria: 1) Helicobacter pylori eradication in the past 2) Patients who must take PPI, antibiotcs or steroids for other purposes 3) Patients taking antiviral agents for AIDS 4) Patients taking P-CAB, PPI, H2 antagonist within 2 weeks prior to screening 5) Patients with acid secretion disorders, Zollinger–Ellison, and who have taken total or subtotal gastrectomy 6) patients with kidney and liver failure with AST, ALT, ALP, ?-GT, total bilirubin level above 2UNL, and BUN, creatinine above 1.5 UNL 7) patients with active gastric bleeding 8) patients with abnormal EKG such as prolonged QT 9) Patients who are unwilling to take contraceptive measures during clinical trial 10) Pregnancy or breastfeeding patients 11) Patients evaluated to be unfil for enrollment 12) patietns with centra nervous infection, hypokalemia, or hypomagnesemia

Design outcomes

Primary

Measure	Time frame
H. pylori eradication rate	—

Secondary

Measure	Time frame
Eradication rate for clarithromycin resistant strains, and medication side effects	—

Countries

Korea, Republic of

Contacts

Public ContactSung Chul Park

Kangwon National University Hospital

schlp@naver.com+82-33-258-2415

Outcome results