drugset / Trial / NCT06823791

Furazolidone Quadruple Regimen Eradicate H. Pylori Infection

NCT06823791

Phase 1/2 Completed 493 enrolled Liaocheng People's Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Research protocol: Experimental group: First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days. Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days. Control group: First line solution (clarithromycin regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 14 days. Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days. Main study endpoint: The difference in the eradication rate of H. pylori infection between the furazolidone quadruple regimen and the clarithromycin quadruple regimen. Secondary study endpoint: 1. Safety and compliance of the furazolidone quadruple regimen. 2. Comparison of high-dose dual therapy with furazolidone quadruple therapy and clarithromycin quadruple therapy on H. pylori eradication rate. 3. 1-year recurrence and recurrence rate of H. pylori infection.

Timeline

Start
2022-08-01
Primary completion
2024-07-30
Completion
2024-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clarithromycin Small molecule 500 mg
Subject Furazolidone Small molecule 100 mg
Background Amoxicillin Other / unclassified 1000 mg
Background Esomeprazole Small molecule 20 mg
Background colloidal bismuth pectin Unknown 200 mg