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Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis

NCT02541045 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-03-15

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

metadoxine

metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months

OTHER

placebo

placebo tablets: 1 Tablet by mouth twice in day during 6 months

Sponsors & Collaborators

  • Hospital General de Mexico

    lead OTHER_GOV

Principal Investigators

  • Fatima Higuera-de la Tijera, MD, MSc. · Hospital General de México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Mexico

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 NCT02541045 on ClinicalTrials.gov