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

NCT02019056 | Completed Phase 2 DMC

• 1 other identifier: MG
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

enteric coated capsule

Drug: Placebo /bid P.O

MG 500mg

EXPERIMENTAL

Metadoxine + garlic oil

Drug: MG-1

MG 1000mg

EXPERIMENTAL

Metadoxine + garlic oil

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

Metadoxine 500mg

SHAM COMPARATOR

enteric coated capsule

Drug: metadoxine

Interventions

Placebo /bid P.O DRUG

Placebo

MG-1 DRUG

Also known as: MG500mg,Placebo /bid P.O

MG 500mg

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

MG 1000mg

metadoxine DRUG

Also known as: placebo, metadoxine 500mg/ bid P.O

Metadoxine 500mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaKing: lead

Study Sites (1)

Hanyang university Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

MeSH Terms

Conditions

Fatty Liver, Alcoholic; Hepatitis, Alcoholic

Interventions

metadoxine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Hepatitis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 24, 2013
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

KR (1)