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NCT00402571 · ClinicalTrials.gov registry record · Phase 4
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
A Phase 4 study, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- Phase 4
- Development phase
- 420
- Enrollment target
NCT00402571: Completed Phase 4 study, sponsored by Denver Health and Hospital Authority.
NCT00402571 is a Phase 4 study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 420 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402571, a Phase 4 study, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 420 participants
- Enrollment target
Study Summary
The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.
Interventions
- DRUG acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2002-01 |
| Est. Completion | 2004-07 |
| Phase | Phase 4 |
What the finished NCT00402571 record still lists
NCT00402571 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 1 intervention - of which acetaminophen is the first listed.
NCT00402571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402571 about?
NCT00402571 is a clinical study titled "Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics". The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and r...
What is the current status of trial NCT00402571?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 420 participants. The study started on 2002-01. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00402571?
The interventions under investigation include: acetaminophen (DRUG).
Who is sponsoring clinical trial NCT00402571?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402571's enrollment target sits among peer trials
420 201st of 2000 higher than 1,799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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