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NCT00427206 · ClinicalTrials.gov registry record · Phase 4

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

A Phase 4 study of Alcohol-Related Disorders, sponsored by Denver Health and Hospital Authority.

Completed
Registry status
Phase 4
Development phase
181
Enrollment target
2
Study locations

NCT00427206 is a Phase 4 study of Alcohol-Related Disorders that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 181 participants, below the 1,756-participant average among 23 other Alcohol-Related Disorders trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00427206, a Phase 4 study of Alcohol-Related Disorders, has completed, sponsored by Denver Health and Hospital Authority.

COMPLETED
Registry status
Phase 4
Development phase
181 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG acetaminophen (4g/day)

Study Locations (2)

Colorado

  • Denver CARES - Denver

Ontario

  • Centre for Addiction and Mental Health - Toronto

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2004-11
Est. Completion 2005-12
Phase Phase 4

What the Registry Record Tells You About NCT00427206

The ClinicalTrials.gov registry entry for NCT00427206 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,756-participant average among 23 other Alcohol-Related Disorders trials with a reported enrollment target (90% lower). The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00427206 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Ontario.

Frequently Asked Questions

What is clinical trial NCT00427206 about?

NCT00427206 is a clinical study titled "Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing". 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 subject...

What is the current status of trial NCT00427206?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2004-11. Estimated completion is 2005-12.

What conditions does trial NCT00427206 study?

This clinical trial studies the following conditions: Alcohol-Related Disorders.

What interventions are being tested in trial NCT00427206?

The interventions under investigation include: placebo (DRUG), acetaminophen (4g/day) (DRUG).

Who is sponsoring clinical trial NCT00427206?

This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00427206 being conducted?

This trial has 2 study locations across Colorado, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.