Alcoholic Fatty Liver DiseasePhase 2NCT02019056
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
A Phase 2 study testing MG-1 and metadoxine in people with Alcoholic Fatty Liver Disease and Alcoholic Hepatitis, run by PharmaKing at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Fatty Liver Disease, Alcoholic Hepatitis
- What is being tested?
- MG-1 and metadoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang university Hospital
Guri-si, Gyeonggi-do, 471-701
About this study
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
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
- Being tested
- Placebo /bid P.O, MG-1, MG-2 : MG1000mg, Placebo /bid P.O, metadoxine
- Medical subject headings
- Fatty Liver, Alcoholic, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo /bid P.ODrug
MG-1Drug
Also called MG500mg,Placebo /bid P.O
MG-2 : MG1000mg, Placebo /bid P.ODrug
metadoxineDrug
Also called placebo, metadoxine 500mg/ bid P.O
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | enteric coated capsule Receives: Drug: Placebo /bid P.O |
| MG 500mg | Experimental | Metadoxine + garlic oil Receives: Drug: MG-1 |
| MG 1000mg | Experimental | Metadoxine + garlic oil Receives: Drug: MG-2 : MG1000mg, Placebo /bid P.O |
| Metadoxine 500mg | Sham comparator | enteric coated capsule Receives: Drug: metadoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 14weeks
To evaluate ALT normalization
To evaluate ALT normalization assessed by comparing the percentage.
Measured: 14weeks
To evaluate AST normalization
To evaluate AST normalization assessed by comparing the percentage.
Measured: 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
Measured: 14weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019056
- Sponsor's protocol ID
- MG
- Status last verified
- Apr 2015
- First submitted
- 30 Oct 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02019056
- Acronym / sponsor ID
- MG
- Conditions
- Alcoholic Fatty Liver Disease, Alcoholic Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo /bid P.Oenteric coated capsule |
| MG 500mg | Experimental | Drug: MG-1Metadoxine + garlic oil |
| MG 1000mg | Experimental | Drug: MG-2 : MG1000mg, Placebo /bid P.OMetadoxine + garlic oil |
| Metadoxine 500mg | Sham comparator | Drug: metadoxineenteric coated capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- •Patients over 18, under 70 years of age
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo /bid P.O | Drug | Placebo |
| MG-1Also: MG500mg,Placebo /bid P.O | Drug | MG 500mg |
| MG-2 : MG1000mg, Placebo /bid P.O | Drug | MG 1000mg |
| metadoxineAlso: placebo, metadoxine 500mg/ bid P.O | Drug | Metadoxine 500mg |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG-1 and metadoxine in people with Alcoholic Fatty Liver Disease and Alcoholic Hepatitis, run by PharmaKing at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in AST at 14weeks (time frame: 14Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.