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

Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ethylene Glycol Poisoning, Methanol Poisoning

Intervention: Fomepizole (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Postmarketing Group Manager, Study Director, Affiliation: Takeda

Overall contact:
Takeda Study Registration Call Center, Phone: +1-800-778-2860 (USA & EU)

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Frequencies of adverse events

Secondary outcome: Change from baseline in arterial blood pH

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients who have been confirmed as receiving the drug

Exclusion Criteria:

-

Locations and Contacts

Takeda Study Registration Call Center, Phone: +1-800-778-2860 (USA & EU)

Osaka, Japan; Recruiting

Tokyo, Japan; Recruiting

Additional Information

Starting date: January 2015
Last updated: August 3, 2015

Page last updated: August 20, 2015

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