drugset / Trial / NCT01273441

Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

NCT01273441

RandomizedParallel-groupOpen-labelTreatment

Summary

Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it is cost-effective. Eradication therapy has changed over time. The usually recommended pattern in the consensus conferences has traditionally been triple therapy, composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after standard triple therapy is less than 80%. Several European studies have found even lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure leads to a second treatment and a new diagnostic test to confirm eradication.

Timeline

Start
2010-12
Primary completion
2012-06
Completion
2012-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g
Subject Clarithromycin Small molecule 500 mg
Subject Metronidazole Small molecule 500 mg
Subject Omeprazole Other / unclassified 20 mg