Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Phase 4
Completed
- Conditions
- Alcohol Related Disorders
- Registration Number
- NCT00402571
- Lead Sponsor
- Denver Health and Hospital Authority
- Brief Summary
The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method mean change in serum aminotransferase levels between study groups
- Secondary Outcome Measures
Name Time Method proportion of subjects tht developed an abnormal aminotransferase level proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L) proportion of subjects that developed drug induced liver injury
Trial Locations
- Locations (2)
Denver CARES
🇺🇸Denver, Colorado, United States
Recovery Centers of King County
🇺🇸Seattle, Washington, United States