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

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

Sponsors

Lead Sponsor: PharmaKing

Source PharmaKing
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.

Overall Status Completed
Start Date 2010-11-01
Completion Date 2014-12-01
Primary Completion Date 2014-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in AST at 14weeks 14Weeks
Number of Participants with Adverse Events (Safety) 14weeks
To evaluate ALT normalization 14weeks
To evaluate AST normalization 14weeks
change in AST, ALT, total lab billirubin lab value 14weeks
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo /bid P.O

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: MG-1

Arm Group Label: MG 500mg

Other Name: MG500mg,Placebo /bid P.O

Intervention Type: Drug

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

Arm Group Label: MG 1000mg

Intervention Type: Drug

Intervention Name: metadoxine

Arm Group Label: Metadoxine 500mg

Other Name: 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Location
Facility: Hanyang university Hospital
Location Countries

Korea, Republic of

Verification Date

2015-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: enteric coated capsule

Label: MG 500mg

Type: Experimental

Description: Metadoxine + garlic oil

Label: MG 1000mg

Type: Experimental

Description: Metadoxine + garlic oil

Label: Metadoxine 500mg

Type: Sham Comparator

Description: enteric coated capsule

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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