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NCT03905798 Clinical Trial

LORA-PITA IV General Investigation

Status Epilepticus Clinical Trial

Official title:
LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03905798
Other study ID # B3541003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 18, 2019
Est. completion date November 15, 2023

Study information
Verified date December 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date November 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Months and older
Eligibility Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Pfizer Local Country office Tokyo Shibuya-ku

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of the participants with adverse reaction 24hrs
Secondary 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. 24hrs
See also
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Enrolling by invitation NCT06403150 - The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus Phase 4
Recruiting NCT05246566 - Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana
Withdrawn NCT04758052 - Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement N/A

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