drugset / Trial / NCT01760824

Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

NCT01760824

Completed 391 enrolled The University of Hong Kong
RandomizedCrossoverOpen-labelTreatment

Summary

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Timeline

Start
2011-05
Primary completion
2012-10
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g
Subject Clarithromycin Small molecule 500 mg
Subject Metronidazole Small molecule 400 mg
Subject Tetracycline Unknown 500 mg
Subject bismuth subcitrate Unknown 120 mg
Background Esomeprazole Small molecule 20 mg