drugset / Trial / NCT01513785

New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection:a Pilot Study

NCT01513785

Phase 2 Completed 40 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

The efficacy of traditional triple therapy has been decreased to such an unacceptable level as 70% in many areas. The study is based on the hypothesis: the most important factors which influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for initial treatment of H. pylori infection.

Timeline

Start
2011-04
Primary completion
2011-10
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rabeprazole Small molecule 10 mg
Comparator Rabeprazole Small molecule 20 mg
Comparator Amoxicillin Other / unclassified 1 g

Indications