Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137059
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2005-08-26
Brief Title:
Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers
Sponsor:
Dr Marco LA Sivilotti
Organization:
Queens University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose This study is designed to look at the interaction between acetaminophen liver injury and alcohol abuse Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days Subjects will have blood work drawn on a daily basis to monitor the status of the liver These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function a-GST Previous work in the investigators group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose Sivilotti 1999 Sivilotti 2002 x 2 However it has never been used to study the alcoholic population The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None