LORA-PITA IV General Investigation

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03905798

Collaborator

(none)

200

Enrollment

Location

48.8

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Status Epilepticus	Drug: Lorazepam

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 18, 2019

Anticipated Primary Completion Date :

Dec 11, 2023

Anticipated Study Completion Date :

Dec 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Lorazepam Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug	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. Other Names: LORA-PITA

Arm

Intervention/Treatment

Lorazepam

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

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.

Other Names:

LORA-PITA

Outcome Measures

Primary Outcome Measures

Number of the participants with adverse reaction [24hrs]

Secondary Outcome 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. [24hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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