Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
- Pediatric patients (45 weeks corrected gestational age to this drug for "sedation during and after mechanical ventilation in the intensive care
setting.
- No exclusion criteria is set out in this study.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Precedex Special Investigation (in Pediatric Patients) | ||||
| Official Title | Precedex Intravenous Injections Special Investigation (Pediatric) | ||||
| Brief Summary | Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan. | ||||
| Detailed Description | To assess the data, including safety profile, of Precedex Intravenous Solution administered for "sedation during and after mechanical ventilation in the intensive care setting" in pediatric patients under actual medical practice in Japan. Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each. | ||||
| 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 | Pediatric patients (45 weeks corrected gestational age to <18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting" | ||||
| Condition | Sedation | ||||
| Intervention | Drug: Dexmedetomidine Hydrochloride [Sedation during and after mechanical ventilation in the intensive care setting] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 ?g/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 ?g/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 ?g/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 ?g/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate. Other Name: Precedex | ||||
| Study Groups/Cohorts | Dexmedetomidine Hydrochloride Pediatric patients (45 weeks corrected gestational age to <18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation during and after mechanical ventilation in the intensive care setting" Intervention: Drug: Dexmedetomidine Hydrochloride | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment | 110 | ||||
| Original Estimated Enrollment | 100 | ||||
| Estimated Study Completion Date | April 8, 2022 | ||||
| Estimated Primary Completion Date | April 8, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
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| Ages | 45 Weeks to 17 Years (Child) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04040439 | ||||
| Other Study ID Numbers | C0801023 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Maruishi Pharmaceutical | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | September 2019 | ||||
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
