Ethylene Glycol Poisoning, Methanol Poisoning Clinical Trial
Official title:
Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
| Verified date | March 2024 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 147 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: -All patients who have been confirmed as receiving the drug Exclusion Criteria: -None |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Takeda Sponsored Site | Osaka | |
| Japan | Takeda Sponsored Site | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | |
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | |
| Primary | Number of Participants Reporting One or More Serious Adverse Events (SAEs) | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | |
| Primary | Number of Participants Who Had One or More Serious Adverse Drug Reactions | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug. | From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days) | |
| Primary | Arterial Blood pH | pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported. | Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) |