Helicobacter pylori infection MedDRA version: 16.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Spiraxin
Pharmaceutical Form: Coated tablet
Sponsors
Javier P. Gisbert
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.- Age more than or equal to 18 years 2.- Dyspeptic patients with persistent or recurrent symptoms, with demonstrated H. pylori infection. 3.- Having been prescribed the standard triple therapy eradication therapy by routine clinical practice. 4.- Haven't begun taking the eradication treatment yet. 5.- Written informed consent of the patient. 6.- The five first patient included in the study must have a blood test scheduled from the outpatient clinic, in the month after the treatment is finished. 7.- If the patient is a woman of childbearing age, is asked to commit to not get pregnant or t use adequate contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1.- Previouse Eradication therapy for H. pylori 2.- Allergy to any of the antibiotic used in the treatment. 3.- Taking antibiotics or bismuth salts after conducting the breath test. 4.- Previous gastric surgery. 5.- Presence of pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumoral severe disease. 6.- Very advanced chronic disease or any other condition that prevents attending to monitoring and control visits. 7.- History of drug or alcohol abuse. 8.- Patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of the addition of rifaximin to a standard triple therapy (inhibitor of proton pump, amoxicillin and clarithromycin) for the eradication of H. pylori;Secondary Objective: Demonstrate good tolerability of the addition of rifaximin to the standard triple therapy Assess adherence of the addition of rifaximin to standard triple therapy;Primary end point(s): Eradication of H. pylori "intention to treat";Timepoint(s) of evaluation of this end point: At least 4 weeks after completion of eradication therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Helicobacter pylori eradication "per protocol". - Treatment compliance. - Medication adverse effects. - Clincal and demographic variables;Timepoint(s) of evaluation of this end point: At least 4 weeks after completion of eradication therapy. | — |
Countries
Spain
Contacts
Public ContactMercedes Ramas
Hospital Universitario de la Princesa
Outcome results
None listed