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| ID | Type | Description | Link |
|---|---|---|---|
| NCT03905798 | Registry Identifier | ClinicalTrials.gov |
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Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorazepam | Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure. |
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Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
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Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local Country office | Tokyo | Shibuya-ku | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LORA-PITA Intravenous Injection 2mg (Lorazepam) | This study was conducted by fixed-point all participants surveillance system in participants who received LORA-PITA as indicated in the approved local product document. The observation period was from the first dose received to 24 hours after the last dose received. A follow-up period was 24 hours after the end of the last dose, and if the follow-up period was less than 24 hours, such participants were deemed as withdrawals. The pediatric (< 16 years) and adult (≥ 16 years) participants' initial doses were 0.25 to 4.00 mg (0.025 to 0.098 mg/kg) and 1.50 to 4.00 mg, respectively. The pediatric and adult participants' second doses were 0.40 to 2.00 mg (0.024 to 0.050 mg/kg) and 2.00 to 4.00 mg, respectively. The pediatric and adult participants' third doses were 0.80 mg (0.024 mg/kg) and 2.00 to 4.00 mg, respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 112 participants completed the study. There were no cases excluded from the safety analysis set, and all 112 cases were included in the safety analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | LORA-PITA Intravenous Injection 2mg (Lorazepam) | This study was conducted by fixed-point all participants surveillance system in participants who received LORA-PITA as indicated in the approved local product document. The observation period was from the first dose received to 24 hours after the last dose received. A follow-up period was 24 hours after the end of the last dose, and if the follow-up period was less than 24 hours, such participants were deemed as withdrawals. The pediatric (< 16 years) and adult (≥ 16 years) participants' initial doses were 0.25 to 4.00 mg (0.025 to 0.098 mg/kg) and 1.50 to 4.00 mg, respectively. The pediatric and adult participants' second doses were 0.40 to 2.00 mg (0.024 to 0.050 mg/kg) and 2.00 to 4.00 mg, respectively. The pediatric and adult participants' third doses were 0.80 mg (0.024 mg/kg) and 2.00 to 4.00 mg, respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received LORA-PITA at least once. Participants without informed consent for notification/publication of study results were excluded. | Posted | Count of Participants | Participants | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. |
|
From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LORA-PITA Intravenous Injection 2mg (Lorazepam) | This study was conducted by fixed-point all participants surveillance system in participants who received LORA-PITA as indicated in the approved local product document. The observation period was from the first dose received to 24 hours after the last dose received. A follow-up period was 24 hours after the end of the last dose, and if the follow-up period was less than 24 hours, such participants were deemed as withdrawals. The pediatric (< 16 years) and adult (≥ 16 years) participants' initial doses were 0.25 to 4.00 mg (0.025 to 0.098 mg/kg) and 1.50 to 4.00 mg, respectively. The pediatric and adult participants' second doses were 0.40 to 2.00 mg (0.024 to 0.050 mg/kg) and 2.00 to 4.00 mg, respectively. The pediatric and adult participants' third doses were 0.80 mg (0.024 mg/kg) and 2.00 to 4.00 mg, respectively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA/J26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA/J26.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2023 | Oct 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2023 | Oct 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| 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) | Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure. | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| LORA-PITA Intravenous Injection 2mg (Lorazepam) |
This study was conducted by fixed-point all participants surveillance system in participants who received LORA-PITA as indicated in the approved local product document. The observation period was from the first dose received to 24 hours after the last dose received. A follow-up period was 24 hours after the end of the last dose, and if the follow-up period was less than 24 hours, such participants were deemed as withdrawals. The pediatric (< 16 years) and adult (≥ 16 years) participants' initial doses were 0.25 to 4.00 mg (0.025 to 0.098 mg/kg) and 1.50 to 4.00 mg, respectively. The pediatric and adult participants' second doses were 0.40 to 2.00 mg (0.024 to 0.050 mg/kg) and 2.00 to 4.00 mg, respectively. The pediatric and adult participants' third doses were 0.80 mg (0.024 mg/kg) and 2.00 to 4.00 mg, respectively. |
|
|
| Secondary | 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) | Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure. | The efficacy analysis set (84 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used as the first-line treatment with evaluable effectiveness, excluding participants who met any of the following conditions: effectiveness evaluation has not been reported at all or the administration was as the second-line treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. |
|
|
|
| Secondary | 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) | Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure. | The efficacy analysis set (104 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used and had evaluable effectiveness data. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. |
|
|
|
| 0 |
| 112 |
| 1 |
| 112 |
| 9 |
| 112 |
| Blood pressure decreased | Investigations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA/J26.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J26.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |