Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fomepizole Intravenous Infusion Fomepizole Intravenous Infusion |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Frequencies of adverse events [Participants will be followed from the first dose of the drug to 24 hours after the last dose of the drug, an expected average of 3 days.]
The frequencies of all adverse reactions observed during the observation period will be tabulated by symptom, day of onset, and severity. An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; an abnormal exacerbation of the target disease (an unexpected exacerbation other than the natural course of the target disease) is also defined as an adverse event; however, an expected exacerbation of the target disease is not considered an adverse event.
Secondary Outcome Measures
- Change from baseline in arterial blood pH [Participants will be followed from the first dose of the drug to 24 hours after the last dose of the drug, an expected average of 3 days.]
Summary statistics for arterial blood pH values and the changes from baseline will be calculated at each time point.
Eligibility Criteria
Criteria
Inclusion Criteria:
-All patients who have been confirmed as receiving the drug
Exclusion Criteria:
-None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Takeda Sponsored Site | Osaka | Japan | ||
| 2 | Takeda Sponsored Site | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Fomepizole-5001
- JapicCTI-152817