ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Obu-shi, Aichi
- Koga, Fukuoka
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kobe, Hyogo
- Sendai, Miyagi
- Ohmura, Nagasaki
- Niigata-shi, Niigata
- Okayama-shi, Okayama
- Izumi, Osaka
- Miyakojima-ku, Osaka
- Shizuoka-city, Shizuoka
- Kodaira, Tokyo
- Kofu, Yamanashi
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Gifu,
- Saitama,
- Tokyo, Shibuya-ku
| 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 | 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 |
| ||||
| Ages | 3 Months and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | July 2020 | ||||