NCT00427206|CompletedPhase 4DMC
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics
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Sponsor study identifier
interventional
181
2 countries
2
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2005
Actual (reported)Study Completion
December 2005
Actual (reported)The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2005
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 2005
Actual (reported)December 2005
Actual (reported)January 24, 2007
Actual (reported)January 26, 2007
Actual (reported)group mean aminotransferase measures
mean change in aminotransferase measures between study groups
proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
proportion of subjects that develop drug induced liver injury
acetaminophen 4 g/day
placebo undistinguishable from active drug
Denver CARES
Denver, Colorado, 80204, United States
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Richard C Dart, MD, PhD
Denver Health/Rocky Mountain Poison & Drug Center
Bruna Brands, PhD
Centre for Addiction and Mental Health
181 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2007
First Posted
January 26, 2007
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors
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Primary Completion
December 2005
Actual (reported)Study Completion
December 2005
Actual (reported)Last Updated
February 9, 2009
Record last verified: 2009-02
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Source: ClinicalTrials.gov.
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