drugset / Trial / NCT02483715

Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

NCT02483715

Phase 4 Completed 589 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication. The aims of this study are: 1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Timeline

Start
2015-07
Primary completion
2018-03
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 750 mg
Comparator Metronidazole Small molecule 250 mg
Subject Rabeprazole Small molecule 20 mg
Comparator Tetracycline Unknown 500 mg
Comparator tripotassium dicitrate bismuthate Unknown 300 mg