LORA-PITA IV General Investigation

NCT03905798 | Completed Results

• 2 other identifiers: B3541003NCT03905798
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Status Epilepticus

Keywords

Status Epilepticus;; Lorazepam;; LORA-PITA;; Ativan

Outcome Measures

Primary Outcomes (1)

• Number of the Participants With Adverse Drug Reactions

  An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to LORA-PITA in a participant who received LORA-PITA. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to LORA-PITA was assessed by the physician.

  From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

Secondary Outcomes (2)

• Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Participants in Whom LORA-PITA Was Used as the First-line Treatment)

  From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

• Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Efficacy Analysis Set)

  From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

Study Arms (1)

Lorazepam

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

Drug: Lorazepam

Interventions

Lorazepam DRUG

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.

Also known as: LORA-PITA

Lorazepam

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Local Country office

Tokyo, Shibuya-ku, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Status Epilepticus

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 5, 2019
• Study Start: November 18, 2019
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)