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

NCT02415712 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2024-03-04

Study results available
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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.

Conditions

  • Ethylene Glycol Poisoning, Methanol Poisoning

Interventions

DRUG

Fomepizole

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.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-27
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02415712 on ClinicalTrials.gov