drugset / Trial / NCT04209933

Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

NCT04209933

Phase 4 Completed 240 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to compare efficacy and safety of bismuth-containing quadruple therapy(with rabeprazole amoxicillin clarithromycin)of different kinds of bismuth(Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles)in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Timeline

Start
2020-05-25
Primary completion
2020-08-01
Completion
2020-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bismuth Potassium Citrate Unknown 220 mg Oral
Comparator Colloidal pectin bismuth Unknown 200 mg Oral
Comparator Colloidal pectin bismuth particles Unknown 150 mg Oral
Comparator Colloidal pectin bismuth particles Unknown 300 mg Oral
Comparator Amoxicillin Other / unclassified 1000 mg Oral
Comparator Clarithromycin Small molecule 500 mg Oral
Comparator Rabeprazole Small molecule 10 mg Oral