CompletedNot Applicable

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

Japan147 participantsStarted 2015-01-27

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

All patients who have been confirmed as receiving the drug

Exclusion criteria

None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Reporting One or More Adverse Events (AEs)

Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)

Number of Participants Who Had One or More Adverse Drug Reactions

Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)

Number of Participants Reporting One or More Serious Adverse Events (SAEs)

Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)

Number of Participants Who Had One or More Serious Adverse Drug Reactions

Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)

Arterial Blood pH

Timeframe: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)

Trial details

NCT IDNCT02415712

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-30

Results submitted2023-06-15

View on ClinicalTrials.gov More Ethylene Glycol Poisoning, Methanol Poisoning trials