Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00661141 · ClinicalTrials.gov registry record · Phase 2
Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00661141 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 32 participants.
The verdict
NCT00661141, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.
Interventions
- DRUG Placebo
- DRUG Antizol
- OTHER Ethanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-04 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00661141
The ClinicalTrials.gov registry entry for NCT00661141 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00661141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00661141 about?
NCT00661141 is a clinical study titled "Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism". This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from e...
What is the current status of trial NCT00661141?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-04. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00661141?
The interventions under investigation include: Placebo (DRUG), Antizol (DRUG), Ethanol (OTHER).
Who is sponsoring clinical trial NCT00661141?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.