MedTrace Logo

Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.

NCT02726269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2016-04-04

No results posted yet for this study

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).

Conditions

  • Helicobacter Pylori Gastritis

Interventions

DRUG

CLA (Clarithro+Lanso+Amoxi)

Tablets of oral administration administered to subjects randomized to this group twice daily for 10 days.

DRUG

PLA (Panto+Levoflox+Azithro)

Tablets of oral administration to subjects randomized to this group once daily for 10 days.

Sponsors & Collaborators

  • Hospital Ángeles, Clínica Londres, Mexico City

    collaborator UNKNOWN

  • Centro InmunoQ, Mexico City

    collaborator UNKNOWN

  • Torre Mayo, Metepec, State of Mexico

    collaborator UNKNOWN

  • Hospital Ángeles Metropolitano, Mexico City

    collaborator UNKNOWN

  • Centro Médico ABC Observatorio, Mexico City

    collaborator UNKNOWN

  • Asofarma de México S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Alma L Ladrón de Guevara, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2014-05-31

More Related Trials

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 NCT02726269 on ClinicalTrials.gov