LORA-PITA IV General Investigation

Overview

Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

Full Title of Study: “LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2023

Detailed Description

To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Interventions

  • Drug: Lorazepam
    • The usual dose of lorazepam in adults is 4 mg administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 4 mg may be added but the dose should not exceed 8 mg as the sum of initial and additional doses. The usual dose of lorazepam in children aged 3 months or older is 0.05 mg/kg (up to 4 mg) administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 0.05 mg/kg may be added but the dose should not exceed 0.1 mg/kg as the sum of initial and additional doses.

Arms, Groups and Cohorts

  • Lorazepam
    • Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug

Clinical Trial Outcome Measures

Primary Measures

  • Number of the participants with adverse reaction
    • Time Frame: 24hrs

Secondary Measures

  • Proportion of patients whose initial seizure stopped within 10 minutes after the administration of final dose and who continued seizure-free for at least 30 minutes.
    • Time Frame: 24hrs

Participating in This Clinical Trial

Inclusion Criteria

Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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