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    Clinical Trial Results:
    COMBINED INTRA ARTICULAR CORTICOSTEROID AND EXERCISE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMISED TRIAL

    Summary
    EudraCT number
    		 2012-002607-18
    Trial protocol
    		 DK  
    Global end of trial date
    07 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions
    Summary report(s)
    		 Publication (2012-002607-18)

    Trial information

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    Trial identification
    Sponsor protocol code
    101.04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01945749
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Parker Institute
    Sponsor organisation address
    Ndr. Fasanvej 57, Copenhagen, Denmark, 20000
    Public contact
    The Parker Institute, The Parker Institute, 0045 38164155, parker@frh.regionh.dk
    Scientific contact
    The Parker Institute, The Parker Institute, 0045 38164155, parker@frh.regionh.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
    07 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of physiotherapeutic exercise in combination with pharmacological antiinflammatory treatment on patient reported pain in patients with knee osteoarthritis.
    Protection of trial subjects
    Treated in routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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
    Denmark: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    59
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screened 263

    Period 1
    Period 1 title
    Baseilne (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
    		 Steroid
    Arm description
    		 Intra-articulr injectino of corticosteoid
    Arm type
    		 Experimental

    Investigational medicinal product name
    Depo-medrol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    40 mg milligram(s)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumklorid isotonisk "SAD"
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1 ml millilitre(s)

    Number of subjects in period 1
    		Steroid Placebo
    Started
    50
    50
    Week2
    50
    50
    Week14
    47
    46
    week26
    45
    44
    Completed
    45
    44
    Not completed
    5
    6
         Lack of time
    3
    1
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Steroid
    Reporting group description
    		 Intra-articulr injectino of corticosteoid

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Steroid Placebo Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 34 25 59
        From 65-84 years
    		 16 25 41
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 28 33 61
        Male
    		 22 17 39
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis sets values
    		 ITT
    Number of subjects
    100
    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)
    59
        From 65-84 years
    41
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Steroid
    Reporting group description
    		 Intra-articulr injectino of corticosteoid

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Primary: Change from baseline in knee pain

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    End point title
    		 Change from baseline in knee pain
    End point description
    End point type
    Primary
    End point timeframe
    Week14
    End point values
    		 Steroid Placebo
    Number of subjects analysed
    50
    50
    Units: points
        least squares mean (standard error)
    13.6 ± 1.8
    14.8 ± 1.8
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Steroid v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 6.2
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week14 Week26
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Steroid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Steroid Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (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: 2%
    Non-serious adverse events
    		 Steroid Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    Injury, poisoning and procedural complications
    Pain in extremity
    Additional description: Increased pain following injection
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2

    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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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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