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Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
NCT00427206 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2004-11 |
| Est. Completion | 2005-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427206
The ClinicalTrials.gov registry entry for NCT00427206 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00427206 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Colorado, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00427206?
The interventions under investigation include: placebo (DRUG), acetaminophen (4g/day) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00427206?
This trial is sponsored by Denver Health and Hospital Authority, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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