Helicobacter Infections Clinical Trial
Official title:
A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut - Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with negative urea breath test post treatment | 30 days post treatment completion, patients will do a Urea Breath Test (a test that is regularly used to check for H. Pylori infection in the stomach) to check whether H. Pylori has been eradicated from the stomach or not. | 30 days post treatment completion | No |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | we will check for nausea, vomiting, metallic taste, diarrhea, and abdominal pain during the 7 days of the treatment period in each patient. | during the 7 days of the treatment | Yes |
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