SedationNCT04040439

Precedex Special Investigation (in Pediatric Patients)

An observational study of Sedation, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan. Read more about this study

Who is it for?: Ages 45 weeks to 17 years
Conditions the study is for: Sedation
What is being tested?: Dexmedetomidine Hydrochloride
Type of treatment: Injection or infusion
How many people: 111 participants
Where: 1 siteJapan
Study dates: 30 Jul 2019to 8 Aug 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 weeks to 17 years
All sexes
No healthy volunteers
Child

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"

Who may be able to join

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.

Who cannot join

No exclusion criteria is set out in this study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Japan Local Country Office
Tokyo

Other trials in Japan

About this study

Official title: Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)

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

Read the 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.

Conditions: Sedation
Being tested: Dexmedetomidine Hydrochloride
Keywords: Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, intensive care;, pediatric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexmedetomidine HydrochlorideDrug
Also called Precedex
[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.

Study groups in NCT04040439
Study group	Role	What they receive
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" Receives: Drug: Dexmedetomidine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions
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.
Measured: 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).

Secondary outcomes (1)

Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
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.
Measured: At the end of administration of Precedex (up to Month 33, at the longest)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 20198 Aug 2022

First posted31 Jul 2019
Study start30 Jul 2019
Primary completion8 Aug 2022
Study completion8 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SedationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04040439
Sponsor's protocol ID: C0801023
Status last verified: Jun 2023
First submitted: 29 Jul 2019
Last updated: 16 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)
ClinicalTrials.gov ID: NCT04040439
Acronym / sponsor ID: C0801023
Conditions: Sedation
Keywords: Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, intensive care;, pediatric
Study type: Observational
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Maruishi Pharmaceutical
Study start: 30 Jul 2019 (actual)
Primary completion: 8 Aug 2022 (actual)
Study completion: 8 Aug 2022 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 16 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Dexmedetomidine Hydrochloride	–	Drug: Dexmedetomidine HydrochloridePediatric 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"

Who may qualify

Ages: 45 weeks to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
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"

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

No exclusion criteria is set out in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexmedetomidine HydrochlorideAlso: Precedex[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.	Drug	Dexmedetomidine Hydrochloride

Primary outcome

Number of Participants With Adverse Drug Reactions
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).
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.

1 secondary outcome

Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
Time frame: At the end of administration of Precedex (up to Month 33, at the longest)

Results and safety

Results posted to the registry on 16 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)	111	98

Primary outcome: Number of Participants With Adverse Drug Reactions

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).. Number. Unit: Participants

Measure	PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) n = 98
ADR	9
Serious ADR	2

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Precedex at least once. Participants with invalid registration or without informed consent were excluded.

1 secondary outcome is reported in the full results.

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride)	4 of 98 (4.1%)	8 of 98 (8.2%)	1 of 98

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

Related trials for Sedation

Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sedation, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.