Ethylene Glycol Poisoning, Methanol PoisoningNCT02415712
Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
An observational study of Ethylene Glycol Poisoning, Methanol Poisoning, run by Takeda at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ethylene Glycol Poisoning, Methanol Poisoning
- What is being tested?
- Fomepizole
- Type of treatment
- Injection or infusion
- How many people
- 147 participants
- Where
- 2 sitesJapan
- Study dates
- 27 Jan 2015to 30 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ethylene glycol poisoning or methanol poisoning
Who may be able to join
- -All patients who have been confirmed as receiving the drug
Who cannot join
- -None
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
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.
Read the 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.
- Being tested
- Fomepizole
- Keywords
- Pharmacotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FomepizoleDrug
Also called Fomepizole Intravenous Infusion 1.5 g
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.
| Study group | Role | What they receive |
|---|---|---|
| Fomepizole Intravenous Infusion | Fomepizole Intravenous Infusion Receives: Drug: Fomepizole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
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.
Measured: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start27 Jan 2015
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ethylene Glycol Poisoning, Methanol PoisoningStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415712
- Sponsor's protocol ID
- Fomepizole-5001
- Other IDs
- jRCT1080222765
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2015
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
- ClinicalTrials.gov ID
- NCT02415712
- Acronym / sponsor ID
- Fomepizole-5001
- Keywords
- Pharmacotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fomepizole Intravenous Infusion | – | Drug: FomepizoleFomepizole Intravenous Infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ethylene glycol poisoning or methanol poisoning
Key inclusion criteria (1 listed)
- -All patients who have been confirmed as receiving the drug
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FomepizoleAlso: Fomepizole Intravenous Infusion 1.5 gThe 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. | Drug | Fomepizole Intravenous Infusion |
Primary outcome
Number of Participants Reporting One or More Adverse Events (AEs)
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
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.
Number of Participants Who Had One or More Adverse Drug Reactions
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
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.
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
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.
Number of Participants Who Had One or More Serious Adverse Drug Reactions
Time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
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.
Arterial Blood pH
Time frame: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethylene Glycol Poisoning, Methanol Poisoning, run by Takeda at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Adverse Events (AEs) (time frame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.