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Sponsors and Collaborators: |
Denver Health and Hospital Authority McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Denver Health and Hospital Authority |
ClinicalTrials.gov Identifier: | NCT00400621 |
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.
Condition | Intervention | Phase |
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Moderate Alcohol Consumption (1-3 Drinks Per Day) |
Drug: acetaminophen |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
Official Title: | Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen: |
Estimated Enrollment: | 150 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | September 2003 |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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:
Exclusion Criteria
Subjects were excluded from the study at baseline if any of the following were evident at baseline:
Principal Investigator: | Kennon Heard, MD | Rocky Mountain Poison Center |
Study ID Numbers: | COMIRB 02-999 |
Study First Received: | November 16, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00400621 |
Health Authority: | United States: Institutional Review Board |
acetaminophen alcohol liver injury |
Drinking Behavior Alcohol Drinking Acetaminophen Ethanol |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |