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

Takeda

Status: Completed

Conditions: Ethylene Glycol Poisoning, Methanol Poisoning

Treatments: Drug: Fomepizole

Study type: Observational

Funder types: Industry

Identifiers

NCT02415712

Fomepizole-5001

jRCT1080222765 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required.

This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g "Takeda," hereinafter referred to as "the drug") was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.

Enrollment: 147 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

-All patients who have been confirmed as receiving the drug

Exclusion criteria

-None

Trial design

147 participants in 1 patient group

Fomepizole Intravenous Infusion

Description:

Fomepizole Intravenous Infusion

Treatment:

Drug: Fomepizole