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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-27

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Stratification and Heterogeneity for Organ Damage in Acute Diquat Poisoning

NCT06798142

Toxic Encephalopathy Diquat Poisoning

ACTIVE_NOT_RECRUITING

Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

NCT05993390

Neuromuscular Blockade Critical Illness Neurologic Findings

RECRUITING NA

Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning

NCT06807151

Diquat Poisoning Blood Purification

COMPLETED

"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

NCT02375217

Anesthesia Recovery

COMPLETED PHASE4

Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization

NCT04258007

Cardiac Catheterization

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ethylene Glycol Poisoning, Methanol Poisoning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fomepizole Intravenous Infusion

Fomepizole

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG