Precedex Special Investigation (in Pediatric Patients)

Completed

• Conditions: Sedation
• Interventions: Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT04040439
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study Start: 2019-07-30
• Study First Posted: 2019-07-31
• Primary Completion: 2022-08-08
• Study Completion: 2022-08-08
• Status Verified: 2023-06
• Results First Submitted: 2023-06-29
• Results First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Results First Posted: 2024-02-16
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

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Exclusion Criteria

• No exclusion criteria is set out in this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Hydrochloride	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"

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	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).	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician	At the end of administration of Precedex (up to Month 33, at the longest)	Overall effectiveness of Precedex was evaluated at the end of Precedex administration by the physician. Clinical effectiveness was evaluated as effective, not effective, or indeterminate by the physician. Clinical effectiveness proportion was defined as the proportion of responders divided by the total number of responders and non-responders.

Trial Locations

Locations (1)

Pfizer Japan Local Country Office; 🇯🇵 Tokyo, Japan