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CompletedNCT02019056Updated Apr 29, 2015

Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis

A Phase 2 interventional study of Placebo /bid P.O and MG-1 in Alcoholic Fatty Liver Disease and Alcoholic Hepatitis, sponsored by PharmaKing. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by PharmaKing · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.

02

Conditions studied

  • Alcoholic Fatty Liver Disease
  • Alcoholic Hepatitis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

PharmaKing is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • •Patients over 18, under 70 years of age

    • The chronic alcohol intake patients

      • Current the heavy drinker over 3month, Day the average alcohol consumption Male>=60g, Female>=40mg y-GTP increase Male>=75, Female>=35
    • Over 1.5 ratio of AST to ALT
    • Patients who have chronoc alcohol disease

Exclusion criteria

Exclusion Criteria:

  • Patients who have liver disease with the cause different with the alcohol except
  • Patients who have pyridoxine allergy or history
  • Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
  • Patients taking other investigational product within 90 days prior to the participation in the study.
  • Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(>=2.5g/day)
  • Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
  • Patient who considered ineligible for participation in the study as Investigator's judgment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    enteric coated capsule

    Drug: Placebo /bid P.O

  • Experimental
    MG 500mg

    Metadoxine + garlic oil

    Drug: MG-1

  • Experimental
    MG 1000mg

    Metadoxine + garlic oil

    Drug: MG-2 : MG1000mg, Placebo /bid P.O

  • Sham comparator
    Metadoxine 500mg

    enteric coated capsule

    Drug: metadoxine

Interventions

  • DrugPlacebo /bid P.O
  • DrugMG-1

    Also known as: MG500mg,Placebo /bid P.O

  • DrugMG-2 : MG1000mg, Placebo /bid P.O
  • Drugmetadoxine

    Also known as: placebo, metadoxine 500mg/ bid P.O

06

What researchers measure

Primary outcomes

  1. Change from Baseline in AST at 14weeks

    To evaluate the liver function to assess improvement of the MG on change in AST lab value assessed from baseline to 12 weeks in patients with Alcoholic fatty liver disease

    Time frame: 14Weeks

  2. Number of Participants with Adverse Events (Safety)

    Adverse Event: Physical examine, Lab test, Vital sign, ECG, symptom, start day and time, end day and time, severity, progress, outcome, relation with investigational product.

    Time frame: 14weeks

  3. To evaluate ALT normalization

    To evaluate ALT normalization assessed by comparing the percentage.

    Time frame: 14weeks

  4. To evaluate AST normalization

    To evaluate AST normalization assessed by comparing the percentage.

    Time frame: 14weeks

  5. change in AST, ALT, total lab billirubin lab value

    To evaluate the efficacy of the MG on change in AST, ALT, total lab billirubin lab value assessed from baseline to 4, 8, 12 weeks in patients with Alcoholic fatty liver disease

    Time frame: 14weeks

07

Study locations

1 site
  • Hanyang university Hospital
    Guri city, Gyeonggi-do 471-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02019056
Lead sponsor
PharmaKing
Responsible party
Sponsor
First posted
Dec 24, 2013
Start date
Nov 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 29, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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