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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled,Phase 2 Study to Evaluate the Efficacy, Safety of MG in Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis

Conditions
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Alcoholic Fatty Liver Disease, Alcoholic Hepatitis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>enteric coated capsule | Drug: Placebo /bid P.O<br> <br> |
| Experimental: MG 500mg<br>Metadoxine + garlic oil | Drug: MG-1<br> <br> * Other names: MG500mg,Placebo /bid P.O;|
| Experimental: MG 1000mg<br>Metadoxine + garlic oil | Drug: MG-2 : MG1000mg, Placebo /bid P.O<br> <br> |
| Sham Comparator: Metadoxine 500mg<br>enteric coated capsule | Drug: metadoxine<br> <br> * Other names: placebo, metadoxine 500mg/ bid P.O;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14Weeks | 
| 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. | 14weeks | 
| To evaluate ALT normalization | To evaluate ALT normalization assessed by comparing the percentage. | 14weeks | 
| To evaluate AST normalization | To evaluate AST normalization assessed by comparing the percentage. | 14weeks | 
| 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 | 14weeks |