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    Clinical Trial Results:
    Pharmacokinetic study of the opioid ketobemidone in children and adolescens after intravenous administration

    Summary
    EudraCT number
    2006-006717-32
    Trial protocol
    SE  
    Global end of trial date
    03 Jun 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    21 May 2021
    First version publication date
    21 May 2021
    Other versions
    Summary report(s)
    Published article 2009

    Trial information

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    Trial identification
    Sponsor protocol code
    554
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Ethics committee Karolinska Institutet Stockholm : 2007/4:1
    Sponsors
    Sponsor organisation name
    Stockholms Läns Landsting
    Sponsor organisation address
    Karolinska University Hospital, Stockholm, Sweden, 17176
    Public contact
    Stefan Lundeberg, Karolinska University Hospital, +46 851777189, stefan.lundeberg@sll.se
    Scientific contact
    Pediatric Pain treatment Service, Karolinska University Hospital, +46 851770000, stefan.lundeberg@sll.se
    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
    03 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of elimination half life of ketobemidone after intravenous injection in children
    Protection of trial subjects
    Postoperative pain management following standard protocol at the hospital. The study drug was part of the pain treatment.
    Background therapy
    Standard analgesic treatment with paracetamol, clonidine and opioids as needed.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    10 Sep 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    5
    Infants and toddlers (28 days-23 months)
    15
    Children (2-11 years)
    10
    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
    30 children who underwent a planned surgical procedure and in need of postoperative opioid treatment.

    Pre-assignment
    Screening details
    31 children were screened and 30 participated and consent was given.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    Ketobemidone
    Arm description
    Study drug used for all enrolled patients
    Arm type
    Experimental

    Investigational medicinal product name
    Ketobemidone hydrochloride
    Investigational medicinal product code
    N02AB01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0.05 mg/kg for neonates and up to 3 months of age, 0.1 mg/kg over the age of 3 months.

    Number of subjects in period 1
    Ketobemidone
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    Three groups: neonates up to 90 days; 1-2.5 years; 7-10 years

    Reporting group values
    Overall trial Total
    Number of subjects
    30 30
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    5 5
        Infants and toddlers (28 days-23 months)
    15 15
        Children (2-11 years)
    10 10
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Children neonates to 3 months (group A) 1 to 2.5 years (groupB) and 7-10 years (groupC)
    Units: years
        median (full range (min-max))
    2.5 (0 to 11) -
    Gender categorical
    Units: Subjects
        Female
    13 13
        Male
    17 17
    Children
    Children aged 0-11 years
    Units: Subjects
        Age
    30 30
    Children
    Children divided in 3 groups
    Units: Age
        median (full range (min-max))
    2.5 (0 to 11) -
    Subject analysis sets

    Subject analysis set title
    Ketobemidone plasma concentration
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Plasma concentration of ketobemidone were analysed. Blood sampling was perfomed at 6 occasions after bolus dose was given.

    Subject analysis set title
    Ketobemidone comparison group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Age groups as described

    Subject analysis sets values
    Ketobemidone plasma concentration Ketobemidone comparison group
    Number of subjects
    30
    24
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    5
        Infants and toddlers (28 days-23 months)
    15
        Children (2-11 years)
    10
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Children neonates to 3 months (group A) 1 to 2.5 years (groupB) and 7-10 years (groupC)
    Units: years
        median (full range (min-max))
    27 (5 to 35)
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    9
    Children
    Children aged 0-11 years
    Units: Subjects
        Age
    30
    Children
    Children divided in 3 groups
    Units: Age
        median (full range (min-max))
    2.5 (0 to 11)

    End points

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    End points reporting groups
    Reporting group title
    Ketobemidone
    Reporting group description
    Study drug used for all enrolled patients

    Subject analysis set title
    Ketobemidone plasma concentration
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Plasma concentration of ketobemidone were analysed. Blood sampling was perfomed at 6 occasions after bolus dose was given.

    Subject analysis set title
    Ketobemidone comparison group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Age groups as described

    Primary: Pharmacokinetic parameter

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    End point title
    Pharmacokinetic parameter
    End point description
    Last patient enrolled
    End point type
    Primary
    End point timeframe
    September 2007 to April 2008
    End point values
    Ketobemidone plasma concentration Ketobemidone comparison group
    Number of subjects analysed
    24
    24
    Units: ng/ml
        number (not applicable)
    24
    24
    Statistical analysis title
    AUC
    Statistical analysis description
    AUC /mg/kg in relation to age groups
    Comparison groups
    Ketobemidone comparison group v Ketobemidone plasma concentration
    Number of subjects included in analysis
    48
    Analysis specification
    Post-hoc
    Analysis type
    other [1]
    P-value
    ≤ 0.05
    Method
    Spearman Rank Correlation
    Confidence interval
    Notes
    [1] - comparison between age groups

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From time of administration of bolus dose of ketobemidone and up to 72 hours post injection.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CRF protocol
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Ketobemidone
    Reporting group description
    Children administered a bolus dose of ketobemidone

    Serious adverse events
    Ketobemidone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Ketobemidone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Nausea was registered in 2 patients but this might have been caused by several factors as the surgical procedure, the anesthesia as well as the post operative analgesics including ketobemidone or other given opioids

    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.
    Nausea as a non serious side effects could be explained by many factors including the use of ketobemidone, surgical procedure and anesthesia.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/19839946
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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