Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 16, 2006

Last Updated Date

November 16, 2006

Start Date ^†

April 2003

Current Primary Outcome Measures ^†

mean change in serum ALT between treatment groups

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

proportion of patients that developed an abnormal ALT
proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
proportion of patients that developed drug induced liver injury

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

Official Title ^†

Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:

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 mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Condition ^†

Moderate Alcohol Consumption (1-3 Drinks Per Day)

Intervention ^†

Drug: acetaminophen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

150

Completion Date

September 2003

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400621

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Denver Health and Hospital Authority

Collaborators ^††

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

Investigators ^†

Principal Investigator:

Kennon Heard, MD

Rocky Mountain Poison Center

Information Provided By

Denver Health and Hospital Authority

Verification Date

November 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.