drugset / Trial / NCT02732249

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

NCT02732249

Phase 4 Completed 66 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupSingle-blindTreatment

Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Timeline

Start
2016-04-01
Primary completion
2017-09-30
Completion
2017-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bismuth Potassium Citrate Unknown 600 mg
Subject Metronidazole Small molecule 400 mg
Background Clarithromycin Small molecule 500 mg
Background Esomeprazole Small molecule 20 mg