Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The goal of this trial is to compare the non-inferiority efficacy and safety of two different
treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily
(PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily
(CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both
schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP
infection. One month after finishing each treatment, C13-urea breath testing will be required
to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance
mutations in HP strains by fluorescence in situ hybridization (FISH).
Phase:
Phase 3
Details
Lead Sponsor:
Asofarma de México S.A de C.V.
Collaborators:
Centro InmunoQ, Mexico City Centro Médico ABC Observatorio, Mexico City Hospital Ángeles Metropolitano, Mexico City Hospital Ángeles, Clínica Londres, Mexico City Torre Mayo, Metepec, State of Mexico