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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 is a Phase 4 study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 420 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402571
The ClinicalTrials.gov registry entry for NCT00402571 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 420 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 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which acetaminophen is the first listed.
NCT00402571 reports 0 study locations.
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.
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