CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 147 enrolled
Drug / intervention
Fomepizoledrug
Likely dose
Fomepizole 15 mg/kgfrom 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/NCT02415712
NCT02415712N/ACompleted

Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)

Takeda·observational·Posted Apr 14, 2015·Updated Mar 4, 2024

In Brief

An observational study evaluating Fomepizole for Ethylene Glycol Poisoning, Methanol Poisoning. Completed, enrolled 147 participants across 2 sites.

Detailed Summary

The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 14, 2015
Enrollment StartJan 27, 2015
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 11.2 years ago

Interventions

Fomepizoledrug

The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.