Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

This study has been completed.

First Received: November 20, 2006 Last Updated: February 6, 2009 History of Changes

Sponsor:	Denver Health and Hospital Authority
Collaborator:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00402571

Purpose

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.

Condition	Intervention	Phase
Alcohol Related Disorders	Drug: acetaminophen	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:

mean change in serum aminotransferase levels between study groups

Secondary Outcome Measures:

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

Estimated Enrollment:	420
Study Start Date:	January 2002
Estimated Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Any patient, regardless of gender or ethnicity, who was:

18 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402571

Locations

United States, Colorado
Denver CARES
Denver, Colorado, United States, 80204
United States, Washington
Recovery Centers of King County
Seattle, Washington, United States, 98122

Sponsors and Collaborators

Denver Health and Hospital Authority

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Investigators

Principal Investigator:

Richard C Dart, MD, PhD

Denver Health/Rocky Mountain Poison & Drug Center

More Information

No publications provided

Study ID Numbers:	COMIRB #00-715
Study First Received:	November 20, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00402571 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:

acetaminophen
alcohol
liver injury

Additional relevant MeSH terms:

Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Substance-Related Disorders
Alcohol-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010