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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Amoxicillin; Clarithromycin; Metronidazole; Rabeprazole

Criteria

Inclusion Criteria:

• documented H.pylori infection by a CLO test or a Urea Breath Test

• sign the informed consent

Exclusion Criteria:

• Age under 18 or older than 80 years

• Allergies to any of the drugs used

• Recent antibiotic therapy (within 2 weeks of enrolment)

• Severe ulcers or bleeding

• Gastric perforation or obstruction

• Previous gastrectomy

• Gastric cancer

• Pregnancy or lactation

• Prior eradication therapy for H. pylori

• Severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.