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

P

PharmaKing

Status and phase

Completed
Phase 2

Conditions

Alcoholic Fatty Liver Disease
Alcoholic Hepatitis

Treatments

Drug: Placebo /bid P.O
Drug: MG-2 : MG1000mg, Placebo /bid P.O
Drug: MG-1
Drug: metadoxine

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
enteric coated capsule
Treatment:
Drug: Placebo /bid P.O
MG 500mg
Experimental group
Description:
Metadoxine + garlic oil
Treatment:
Drug: MG-1
MG 1000mg
Experimental group
Description:
Metadoxine + garlic oil
Treatment:
Drug: MG-2 : MG1000mg, Placebo /bid P.O
Metadoxine 500mg
Sham Comparator group
Description:
enteric coated capsule
Treatment:
Drug: metadoxine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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