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

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ClinicalTrials.gov Identifier: NCT02415712
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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
Ethylene Glycol Poisoning, Methanol Poisoning Drug: Fomepizole

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.


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Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
Actual Study Start Date : January 27, 2015
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning
Drug Information available for: Fomepizole

Group/Cohort 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 Name: Fomepizole Intravenous Infusion 1.5 g




Primary Outcome Measures :
  1. Frequencies of adverse events [ Time Frame: 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 :
  1. Change from baseline in arterial blood pH [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ethylene glycol poisoning or methanol poisoning
Criteria

Inclusion Criteria:

  • All patients who have been confirmed as receiving the drug

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415712


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Japan
Takeda Sponsored Site Recruiting
Osaka, Japan
Takeda Sponsored Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Postmarketing Group Manager Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02415712     History of Changes
Other Study ID Numbers: Fomepizole-5001
JapicCTI-152817 ( Registry Identifier: JapicCTI )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Pharmacotherapy

Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders
Fomepizole
Antidotes
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action