Trials / Completed
CompletedNCT00402571
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 420 (planned)
- Sponsor
- Denver Health and Hospital Authority · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | acetaminophen |
Timeline
- Start date
- 2002-01-01
- Completion
- 2004-07-01
- First posted
- 2006-11-22
- Last updated
- 2009-02-09
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00402571. Inclusion in this directory is not an endorsement.