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    The EU Clinical Trials Register currently displays   41493   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after periacetabular osteotomy- a randomized, double-blind, controlled trial.

    Summary
    EudraCT number
    2017-000544-17
    Trial protocol
    DK  
    Global end of trial date
    20 Sep 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Apr 2020
    First version publication date
    19 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXGANZ01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03161938
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Eske K Aasvang
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 31666112, kjs@dadlnet.dk
    Scientific contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 31666112 31666112, kjs@dadlnet.dk
    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 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effects of high versus low dose glucorticoids on pain after periacetabular osteotomy
    Protection of trial subjects
    All trial subjects underwent standard procedures, only difference was the dosage of dexamethasone
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 2017
    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
    Denmark: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Denmark, 1/5-2017 to 20/8-2019

    Pre-assignment
    Screening details
    Eligible patients are informed about the trial in relation to the pre-operative appointment. Enrolled participants are randomized and assigned to consecutive numbers (1-64) at the morning of surgery. Inclusion criteria • Planned PAO • Age 18 years or older • Able to understand Danish or English and to provide informed oral and written consent

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    48 mg dexamethasone
    Arm description
    48 mg dexamethasone
    Arm type
    Experimental

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    single-dose intravenous

    Arm title
    8 mg dexamethasone
    Arm description
    8 mg dexamethasone
    Arm type
    Active comparator

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    single-dose intravenous

    Number of subjects in period 1
    48 mg dexamethasone 8 mg dexamethasone
    Started
    32
    32
    Completed
    32
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall
    Reporting group description
    -

    Reporting group values
    overall Total
    Number of subjects
    64 64
    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
        arithmetic mean (standard deviation)
    29 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    51 51
        Male
    13 13

    End points

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    End points reporting groups
    Reporting group title
    48 mg dexamethasone
    Reporting group description
    48 mg dexamethasone

    Reporting group title
    8 mg dexamethasone
    Reporting group description
    8 mg dexamethasone

    Primary: Pain in the PACU

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    End point title
    Pain in the PACU
    End point description
    The primary endpoint was the proportion of patients reporting moderate to severe pain at rest (>3 out of 10 on a Numeric Rating Scale from 0-10 (NRS)) in the immediate postoperative phase (after extubation in the operating room, and in the PACU until transfer to the ward).
    End point type
    Primary
    End point timeframe
    12 hours
    End point values
    48 mg dexamethasone 8 mg dexamethasone
    Number of subjects analysed
    32
    32
    Units: participants
    26
    22
    Statistical analysis title
    primary outcome fischers
    Comparison groups
    48 mg dexamethasone v 8 mg dexamethasone
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.248
    Method
    Chi-squared corrected
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.508
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.159
         upper limit
    1.62

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    60 hours after administration of trial drug
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    10
    Reporting groups
    Reporting group title
    48 mg dexamethasone
    Reporting group description
    48 mg dexamethasone

    Reporting group title
    8 mg dexamethasone
    Reporting group description
    8 mg dexamethasone

    Serious adverse events
    48 mg dexamethasone 8 mg dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Arterial injury
    Additional description: gluteal artery damage, iatrogenic intraoperative
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    48 mg dexamethasone 8 mg dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 32 (21.88%)
    4 / 32 (12.50%)
    Ear and labyrinth disorders
    Dizziness postural
    Additional description: dizziness at mobilization
         subjects affected / exposed
    7 / 32 (21.88%)
    4 / 32 (12.50%)
         occurrences all number
    7
    4

    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
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