Overview

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.