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Precedex Special Investigation (in Pediatric Patients)

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ClinicalTrials.gov Identifier: NCT04040439
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Condition or disease Intervention/treatment
Sedation Drug: Dexmedetomidine Hydrochloride

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Precedex Intravenous Solution Special Investigation (in Pediatric Patients)
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : April 8, 2022
Estimated Study Completion Date : April 8, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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"
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 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/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 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/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




Primary Outcome Measures :
  1. Number of participants with adverse drug reactions (ADRs) [ Time Frame: From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU)(up to Month 33, at the longest) ]
    Regarding Time Frame, if a participant leaves the ICU before 24 hours after the end of administration of Precedex, adverse events (AEs) observed up to 24 hours after the end of administration should be entered in the case report form (CRF) as much as possible, and the AEs should be monitored until the outcomes become known as far as possible.


Secondary Outcome Measures :
  1. Percentage of participants who are evaluated as effective (responders) by the investigator [ Time Frame: At the end of administration of Precedex (up to Month 33, at the longest) ]
    Effectiveness evaluation (effective, not effective, or indeterminate) of Precedex will be performed by investigators at the end of administration of this drug.



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Ages Eligible for Study:   45 Weeks to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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"
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No exclusion criteria is set out in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040439


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
Pfizer Japan Local Country Office Not yet recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Maruishi Pharmaceutical
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04040439     History of Changes
Other Study ID Numbers: C0801023
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Pfizer:
Precedex;
Dexmedetomidine Hydrochloride;
Sedation;
intensive care;
pediatric
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action