LORA-PITA IV General Investigation

NCT03905798

Last updated date
Study Location
Pfizer Local Country office
Tokyo, Shibuya-ku, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Status Epilepticus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3 + months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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Status EpilepticusLORA-PITA IV General Investigation
NCT03905798
  1. Tokyo, Shibuya-ku
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title LORA-PITA IV General Investigation
Official Title Drug Use Investigation
Brief Summary Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
Detailed Description To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Status Epilepticus
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.

Other Name: LORA-PITA
Study Groups/Cohorts Lorazepam
Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug
Intervention: Drug: Lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 4, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 13, 2022
Estimated Primary Completion Date September 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Sex/Gender
Sexes Eligible for Study:All
Ages 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03905798
Other Study ID Numbers B3541003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020