Trial Outcomes & Findings for LORA-PITA IV General Investigation (NCT NCT03905798)
NCT ID: NCT03905798
Last Updated: 2025-03-10
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
206 participants
Primary outcome timeframe
From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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206
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Overall Study
COMPLETED
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112
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Overall Study
NOT COMPLETED
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94
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Reasons for withdrawal
| Measure |
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.
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Overall Study
No informed consent for notification/publication of study results
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94
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=112 Participants
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.
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|---|---|
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Age, Customized
<16 years
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23 Participants
n=112 Participants
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Age, Customized
≥16 and <65 years
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40 Participants
n=112 Participants
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Age, Customized
≥65 years
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49 Participants
n=112 Participants
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Sex: Female, Male
Female
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49 Participants
n=112 Participants
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Sex: Female, Male
Male
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63 Participants
n=112 Participants
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PRIMARY outcome
Timeframe: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.Population: 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.
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.
Outcome measures
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=112 Participants
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.
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Number of the Participants With Adverse Drug Reactions
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7 Participants
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SECONDARY outcome
Timeframe: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.Population: 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.
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.
Outcome measures
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=84 Participants
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.
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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)
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64.3 Percentage of Participants
Interval 53.1 to 74.4
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SECONDARY outcome
Timeframe: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.Population: 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.
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.
Outcome measures
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=104 Participants
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.
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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)
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62.5 Percentage of Participants
Interval 52.5 to 71.8
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Adverse Events
LORA-PITA Intravenous Injection 2mg (Lorazepam)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=112 participants at risk
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.
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Cardiac disorders
Ventricular tachycardia
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0.89%
1/112 • 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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Other adverse events
| Measure |
LORA-PITA Intravenous Injection 2mg (Lorazepam)
n=112 participants at risk
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.
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|---|---|
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Cardiac disorders
Bradycardia
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0.89%
1/112 • 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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Investigations
Blood pressure decreased
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1.8%
2/112 • 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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Investigations
Lymphocyte count decreased
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0.89%
1/112 • 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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Renal and urinary disorders
Renal impairment
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0.89%
1/112 • 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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Respiratory, thoracic and mediastinal disorders
Respiratory arrest
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0.89%
1/112 • 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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Respiratory, thoracic and mediastinal disorders
Respiratory depression
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0.89%
1/112 • 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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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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2.7%
3/112 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER