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

NCT01219764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-01-27

No results posted yet for this study

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.

Conditions

  • Helicobacter Infections

Interventions

DRUG

Rabeprazole, metronidazole, Clarithromycin, Amoxicillin

Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days. Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Ala' I Sharara, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219764 on ClinicalTrials.gov