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LORA-PITA IV General Investigation

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ClinicalTrials.gov Identifier: NCT03905798
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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
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
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Study Type : Observational
Estimated 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 : November 18, 2019
Estimated Primary Completion Date : November 7, 2023
Estimated Study Completion Date : November 7, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

Groups and Cohorts
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Group/Cohort 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 Name: LORA-PITA


Outcome Measures
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Primary Outcome Measures :
  1. Number of the participants with adverse reaction [ Time Frame: 24hrs ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Criteria
Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Contacts and Locations
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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): NCT03905798


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
Pfizer Local Country office Recruiting
Tokyo, Shibuya-ku, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03905798    
Other Study ID Numbers: B3541003
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Status Epilepticus;
Lorazepam;
LORA-PITA;
Ativan
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action