Back to resultsEfficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
Primary Purpose
Alcoholic Fatty Liver Disease, Alcoholic Hepatitis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo /bid P.O
MG-1
MG-2 : MG1000mg, Placebo /bid P.O
metadoxine
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Fatty Liver Disease
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
Sites / Locations
- Hanyang university Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Sham Comparator
Arm Label
Placebo
MG 500mg
MG 1000mg
Metadoxine 500mg
Arm Description
enteric coated capsule
Metadoxine + garlic oil
Metadoxine + garlic oil
enteric coated capsule
Outcomes
Primary Outcome Measures
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
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.
To evaluate ALT normalization
To evaluate ALT normalization assessed by comparing the percentage.
To evaluate AST normalization
To evaluate AST normalization assessed by comparing the percentage.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02019056
Brief Title
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaKing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Fatty Liver Disease, Alcoholic Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
enteric coated capsule
Arm Title
MG 500mg
Arm Type
Experimental
Arm Description
Metadoxine + garlic oil
Arm Title
MG 1000mg
Arm Type
Experimental
Arm Description
Metadoxine + garlic oil
Arm Title
Metadoxine 500mg
Arm Type
Sham Comparator
Arm Description
enteric coated capsule
Intervention Type
Drug
Intervention Name(s)
Placebo /bid P.O
Intervention Type
Drug
Intervention Name(s)
MG-1
Other Intervention Name(s)
MG500mg,Placebo /bid P.O
Intervention Type
Drug
Intervention Name(s)
MG-2 : MG1000mg, Placebo /bid P.O
Intervention Type
Drug
Intervention Name(s)
metadoxine
Other Intervention Name(s)
placebo, metadoxine 500mg/ bid P.O
Primary Outcome Measure Information:
Title
Change from Baseline in AST at 14weeks
Description
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
Time Frame
14Weeks
Title
Number of Participants with Adverse Events (Safety)
Description
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.
Time Frame
14weeks
Title
To evaluate ALT normalization
Description
To evaluate ALT normalization assessed by comparing the percentage.
Time Frame
14weeks
Title
To evaluate AST normalization
Description
To evaluate AST normalization assessed by comparing the percentage.
Time Frame
14weeks
Title
change in AST, ALT, total lab billirubin lab value
Description
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
Time Frame
14weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hanyang university Hospital
City
Guri city
State/Province
Gyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
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