Trials / Completed
CompletedNCT03905798
LORA-PITA IV General Investigation
LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 206 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2023-11-15
- Completion
- 2023-11-15
- First posted
- 2019-04-05
- Last updated
- 2025-03-10
- Results posted
- 2025-03-10
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03905798. Inclusion in this directory is not an endorsement.