drugset / Trial / NCT03609892

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

NCT03609892

Phase 4 Completed 658 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Timeline

Start
2018-08-01
Primary completion
2019-08-20
Completion
2019-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg
Subject Berberine Traditional medicine (herbal / TCM) 300 mg
Comparator Furazolidone Small molecule 100 mg
Comparator Tetracycline Unknown 500 mg
Comparator Bismuth Potassium Citrate Unknown 200 mg
Comparator Esomeprazole Small molecule 20 mg