A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection

Summary

The proposed study will test the hypothesis that H. pylori can be eradicated successfully (\>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis. Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.

Timeline

Start

2010-10

Primary completion

2013-03

Completion

2013-03

Drugs

Indications