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    Clinical Trial Results:
    Bioavailability and pharmacokinetics of intranasal dexmedetomidine in children

    Summary
    EudraCT number
    		 2016-002880-33
    Trial protocol
    		 FI  
    Global end of trial date
    10 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2020
    First version publication date
    25 Oct 2020
    Other versions
    Summary report(s)
    		 PINDEX_article

    Trial information

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    Trial identification
    Sponsor protocol code
    PINDEX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Turku
    Sponsor organisation address
    Kiinamyllynkatu 4-8, Turku, Finland,
    Public contact
    Turku Clinical Research Centre, Turku University Hospital, turkucrc@tyks.fi
    Scientific contact
    Turku Clinical Research Centre, Turku University Hospital, turkucrc@tyks.fi
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aim to characterize the pharmacokinetics of dexmedetomidine after intranasal dosing.
    Protection of trial subjects
    Normal hospital routines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    8
    Children (2-11 years)
    47
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients (and their guardians) potentially eligible for the study were approached for information, assessment of eligibility criteria, and consent either during a preceding clinic visit or on arrival in the hospital for the procedure.

    Pre-assignment
    Screening details
    		 Patients potentially eligible (155) for the study were approached for information, assessment of eligibility criteria, and consent either during a preceding clinic visit or on arrival in the hospital for the procedure. Written informed consent was obtained from 55 patients.

    Pre-assignment period milestones
    Number of subjects started
    		 55
    Intermediate milestone: Number of subjects
    Informed consent: 55
    Number of subjects completed
    		 55

    Period 1
    Period 1 title
    Study clinical phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IN dexmedetomidine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution in single-dose container
    Routes of administration
    Intranasal use
    Dosage and administration details
    A dose of 2–3 μg·kg−1 of dexmedetomidine (dexmedetomidine hydrochloride 118 μg·milliliter−1, corresponding to dexmedetomidine base 100 μg·milliliter−1, Dexdor; Orion Pharma, Espoo, Finland) was administered IN using an LMA® MAD NasalTM device (Teleflex MAD Nasal; Teleflex Inc, Research Triangle Park, NC) approximately 45–60 minutes before the scheduled MRI procedure

    Number of subjects in period 1
    		IN dexmedetomidine
    Started
    55
    Clinical phase ended
    55
    Completed
    50
    Not completed
    5
         Protocol deviation
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study clinical phase
    Reporting group description
    		 -

    Reporting group values
    		 Study clinical phase Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 5.0 ± 2.4 -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 28 28
    Ethnic group
    Units: Subjects
        Caucasian
    		 55 55
    Subject analysis sets

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Our primary outcome was to determine the peak plasma concentrations (Cmax) and time to Cmax (tmax) after IN dexmedetomidine. We hypothesized that IN 2–3 μg·kg−1 dexmedetomidine leads to previously defined clinically effective plasma concentrations and coincide with the onset of action during MRI sedation in pediatric patients. Our secondary outcomes were area under time–concentration curve from 0 to 4 hours (AUC0–4h) and the pharmacological effects caused by single IN dexmedetomidine to pharmacokinetics during pediatric sedation. We also evaluated the effect of age on dexmedetomidine pharmacokinetics and the effect our dosing regimen had on inducing clinically significant sedative effects in this patient population.

    Subject analysis sets values
    		 Final analysis
    Number of subjects
    1
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (standard deviation)
    5.0 ± 2.4
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    25
    Ethnic group
    Units: Subjects
        Caucasian
    50

    End points

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    End points reporting groups
    Reporting group title
    IN dexmedetomidine
    Reporting group description
    		 -

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Our primary outcome was to determine the peak plasma concentrations (Cmax) and time to Cmax (tmax) after IN dexmedetomidine. We hypothesized that IN 2–3 μg·kg−1 dexmedetomidine leads to previously defined clinically effective plasma concentrations and coincide with the onset of action during MRI sedation in pediatric patients. Our secondary outcomes were area under time–concentration curve from 0 to 4 hours (AUC0–4h) and the pharmacological effects caused by single IN dexmedetomidine to pharmacokinetics during pediatric sedation. We also evaluated the effect of age on dexmedetomidine pharmacokinetics and the effect our dosing regimen had on inducing clinically significant sedative effects in this patient population.

    Primary: Peak plasma concentration

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    End point title
    		 Peak plasma concentration
    End point description
    End point type
    Primary
    End point timeframe
    0-4 hours
    End point values
    		 IN dexmedetomidine Final analysis
    Number of subjects analysed
    50
    50
    Units: nanogram(s)/milliliter
        arithmetic mean (standard deviation)
    0.0011 ± 0.0051
    0.0011 ± 0.0051
    Statistical analysis title
    		 Final analysis
    Statistical analysis description
    descriptive analysis
    Comparison groups
    IN dexmedetomidine v Final analysis
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - descriptive analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During administration of IN dexmedetomidine and thereafter at 1, 2, 3, and 4 hours after dosing
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    IN dexmedetomidine
    Reporting group description
    		 -

    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 IN dexmedetomidine All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 IN dexmedetomidine All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    Cardiac disorders
    Bradycardia
    Additional description: One patient (5 years, 17 kg) received a single dose of atropine for bradycardia of 36 minute−1, occurring soon after dosing of thiopental, 57 minutes after dexmedetomidine
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31206433
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