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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by PharmaKing
Sponsor:
Information provided by (Responsible Party):
PharmaKing
ClinicalTrials.gov Identifier:
NCT02019056
First received: October 30, 2013
Last updated: December 17, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate ALT normalization assessed by comparing the percentage.

  • To evaluate AST normalization [ Time Frame: 14weeks ] [ Designated as safety issue: No ]
    To evaluate AST normalization assessed by comparing the percentage.

  • change in AST, ALT, total lab billirubin lab value [ Time Frame: 14weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 88
Study Start Date: November 2010
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019056

Contacts
Contact: SooHyun Lee 82-31-739-3344 isuclala@gmail.com

Locations
Korea, Republic of
Hanyang university Hospital Recruiting
Guri city, Gyeonggi-do, Korea, Republic of, 471-701
Contact: Misoon Park    82-31-554-3115    circle0@hmc.hanyang.ac.kr   
Sponsors and Collaborators
PharmaKing
  More Information

No publications provided

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT02019056     History of Changes
Other Study ID Numbers: MG
Study First Received: October 30, 2013
Last Updated: December 17, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Fatty Liver
Fatty Liver, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases, Alcoholic
Picornaviridae Infections
RNA Virus Infections
Substance-Related Disorders
Virus Diseases
Metadoxine
Alcohol Deterrents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014