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

NCT ID: NCT02019056

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Alcoholic Fatty Liver Disease; Alcoholic Hepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

enteric coated capsule

Group Type: PLACEBO_COMPARATOR

Placebo /bid P.O

Intervention Type: DRUG

MG 500mg

Metadoxine + garlic oil

Group Type: EXPERIMENTAL

MG-1

Intervention Type: DRUG

MG 1000mg

Metadoxine + garlic oil

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Metadoxine 500mg

enteric coated capsule

Group Type: SHAM_COMPARATOR

metadoxine

Intervention Type: DRUG

Interventions

Placebo /bid P.O

Intervention Type: DRUG

MG-1

Intervention Type: DRUG

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

Intervention Type: DRUG

metadoxine

Intervention Type: DRUG

Other Intervention Names

MG500mg,Placebo /bid P.O; placebo, metadoxine 500mg/ bid P.O

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaKing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hanyang university Hospital

Guri-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

MG

Identifier Type: -

Identifier Source: org_study_id