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
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