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

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

NCT02019056

MG

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

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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