We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02019056
First Posted: December 24, 2013
Last Update Posted: April 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaKing
  Purpose
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.

Condition Intervention Phase
Alcoholic Fatty Liver Disease Alcoholic Hepatitis Drug: Placebo /bid P.O Drug: MG-1 Drug: MG-2 : MG1000mg, Placebo /bid P.O Drug: metadoxine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PharmaKing:

Primary Outcome Measures:
  • Change from Baseline in AST at 14weeks [ Time Frame: 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

  • Number of Participants with Adverse Events (Safety) [ Time Frame: 14weeks ]
    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.

  • To evaluate ALT normalization [ Time Frame: 14weeks ]
    To evaluate ALT normalization assessed by comparing the percentage.

  • To evaluate AST normalization [ Time Frame: 14weeks ]
    To evaluate AST normalization assessed by comparing the percentage.

  • change in AST, ALT, total lab billirubin lab value [ Time Frame: 14weeks ]
    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


Enrollment: 90
Study Start Date: November 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
enteric coated capsule
Drug: Placebo /bid P.O
Experimental: MG 500mg
Metadoxine + garlic oil
Drug: MG-1
Other Name: MG500mg,Placebo /bid P.O
Experimental: MG 1000mg
Metadoxine + garlic oil
Drug: MG-2 : MG1000mg, Placebo /bid P.O
Sham Comparator: Metadoxine 500mg
enteric coated capsule
Drug: metadoxine
Other Name: placebo, metadoxine 500mg/ bid P.O

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019056


Locations
Korea, Republic of
Hanyang university Hospital
Guri city, Gyeonggi-do, Korea, Republic of, 471-701
Sponsors and Collaborators
PharmaKing
  More Information

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT02019056     History of Changes
Other Study ID Numbers: MG
First Submitted: October 30, 2013
First Posted: December 24, 2013
Last Update Posted: April 29, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Fatty Liver
Hepatitis, Alcoholic
Fatty Liver, Alcoholic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Metadoxine
Pyridoxine
Alcohol Deterrents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs