CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Antizol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661141
NCT00661141Phase 2Completed
CompareCT.gov

A Phase IIa, Prospective, Randomized, Blinded, Intra-Subject Controlled, Single Dose, Dose Escalation Study of Antizol® for Mitigation of Acetaldehyde Related Toxicity in Human Subjects With Symptoms of Inborn Altered Ethanol Metabolism With Concomitant Ethanol Exposure

Amgen·interventional·Posted Apr 18, 2008·Updated Dec 27, 2024

In Brief

A Phase 2 clinical trial evaluating Antizol, Placebo, and 1 other intervention for Aldehyde Dehydrogenase-2 (ALDH2) Deficiency. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAldehyde Dehydrogenase-2 (ALDH2) Deficiency
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.2 years ago

Interventions

Antizoldrug

Placebodrug

Ethanolother

oral dose of ethanol (0.5 g/kg)