drugset / Trial / NCT01792700

Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

NCT01792700

Phase 4 Completed 648 enrolled Seoul National University Bundang Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.

Timeline

Start
2003-01
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 1000 mg
Comparator Esomeprazole Small molecule 20 mg
Comparator Metronidazole Small molecule 500 mg
Comparator Moxifloxacin Small molecule 400 mg
Comparator Tetracycline Unknown 500 mg
Comparator tripotassium dicitrate bismuthate Unknown 300 mg