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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing
• Treatments: Metadoxine; Pyridoxine

Criteria

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