Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400621
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2006-11-16
Brief Title:
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers
Sponsor:
Denver Health and Hospital Authority
Organization:
Denver Health and Hospital Authority
Study Overview
Official Title:
Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen
Status:
COMPLETED
Status Verified Date:
2006-11
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:
The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers The main outcome was liver injury measured by an increase in mean serum ALT or AST levels Patients were randomly assigned to 10 days of acetaminophen or placebo Blood tests were measured at baseline day 4 and day 11 to look for injury We hypothesized that there would be no difference in liver enzymes between the two groups
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