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
1 other identifier
interventional
420
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2002
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 20, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedFebruary 9, 2009
February 1, 2009
November 20, 2006
February 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean change in serum aminotransferase levels between study groups
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Any patient, regardless of gender or ethnicity, who was:
- years or older
- admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
- signed a written informed consent form.
- Patients were excluded from the study at baseline if any of the following were present:
- serum acetaminophen level greater than 20 mcg/ml
- serum AST or ALT levels greater than 200 IU/L
- INR greater than 1.5
- if female, positive for beta-subunit of chorionic gonadotropin
- clinically intoxicated, psychiatrically impaired or unable to give informed consent
- known hypersensitivity to acetaminophen
- history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
- currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Denver CARES
Denver, Colorado, 80204, United States
Recovery Centers of King County
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard C Dart, MD, PhD
Denver Health/Rocky Mountain Poison & Drug Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 20, 2006
First Posted
November 22, 2006
Study Start
January 1, 2002
Study Completion
July 1, 2004
Last Updated
February 9, 2009
Record last verified: 2009-02