Status:
COMPLETED
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Moderate Alcohol Consumption (1-3 Drinks Per Day)
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in ...
Eligibility Criteria
Inclusion
- Inclusion criteria Adult volunteers of age 21 years or older, regardless of ethnicity or gender, who provided written consent and met all three of the following criteria of a moderate alcohol consumer:
- Average baseline ethanol consumption of at least one alcoholic beverage per day before enrollment for the past two months. The estimate of ethanol intake was based on the average intake over seven days. For example, a person who ingested no alcohol on Sunday, Monday, Tuesday or Wednesday, two drinks on Thursday and four drinks on Friday and Saturday would be calculated as 10 drinks/7days = 1.4 drinks/day. The average alcoholic beverage contains 15 grams of alcohol(9).
- Average baseline ethanol consumption of no more than three alcoholic beverages (\> 45 grams of alcohol) per day, calculated as a weekly average over the preceding two months.
- At least one alcohol-containing drink within the last 48 hours
- Exclusion Criteria
- Subjects were excluded from the study at baseline if any of the following were evident at baseline:
- Serum acetaminophen level greater than 20 mcg/ml
- Serum AST or ALT levels greater than 50 IU/L
- If female, positive for b-HCG
- Clinically intoxicated, psychiatrically impaired or unable to give informed consent
- Known hypersensitivity to acetaminophen
- History of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment
- Alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily
- Currently enrolled in another trial or had been enrolled in another trial in the preceding three months
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00400621
Start Date
April 1 2003
End Date
September 1 2003
Last Update
July 8 2024
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