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LORA-PITA IV General Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 4, 2019
First Posted Date April 5, 2019
Last Update Posted Date June 1, 2023
Actual Study Start Date November 18, 2019
Estimated Primary Completion Date November 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2019)		 Number of the participants with adverse reaction [ Time Frame: 24hrs ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2019)		 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LORA-PITA IV General Investigation
Official Title LORA-PITA (REGISTERED) Intravenous Injection 2 mg General 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 November 7, 2023
Estimated Primary Completion Date November 7, 2023   (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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor Pfizer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2023