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    Clinical Trial Results:
    Paracetamol or NSAID's in acute musculoskeletal syndromes

    Summary
    EudraCT number
    		 2013-000381-11
    Trial protocol
    		 NL  
    Global end of trial date
    01 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions
    Summary report(s)
    		 Journal article

    Trial information

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    Trial identification
    Sponsor protocol code
    NL42823.018.13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR3982
    Sponsors
    Sponsor organisation name
    Amsterdam UMC location AMC
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands,
    Public contact
    Emergency Department, Academisch Medisch Centrum, 0031 0205663336, m.l.ridderikhof@amc.uva.nl
    Scientific contact
    Emergency Department, Academisch Medisch Centrum, 0031 0205663336, m.l.ridderikhof@amc.uva.nl
    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
    31 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the effect in treatment of pain with three different strategies of pain management in patients presenting to an Emergency Department and to a general practice with acute musculoskeletal syndromes (defined as musculoskeletal complaints after sustaining an injury with exclusion of a fracture). The strategies of pain management which will be compared are paracetamol, diclofenac and the combination of paracetamol and diclofenac.
    Protection of trial subjects
    NA
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    01 Jun 2013
    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
    Netherlands: 547
    Worldwide total number of subjects
    547
    EEA total number of subjects
    547
    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)
    505
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 - Adult patients (18 years and older) - Presenting to 2 university EDs; and urgent care center and one general practice - Non-penetrating minor musculoskeletal injuries of an extremity - WIthin 48 hours prior to presentation

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paracetamol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4x1000mg in a blinded fashion

    Arm title
    		 Diclofenac
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diclofenac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x50mg in a blinded fashion

    Arm title
    		 Paracetamol and Diclofenac
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paracetamol and Diclofenac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paracetamol 4x1000mg and Diclofenac 3x50mg

    Number of subjects in period 1
    		Paracetamol Diclofenac Paracetamol and Diclofenac
    Started
    182
    183
    182
    Completed
    182
    183
    182

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Paracetamol
    Reporting group description
    		 -

    Reporting group title
    Diclofenac
    Reporting group description
    		 -

    Reporting group title
    Paracetamol and Diclofenac
    Reporting group description
    		 -

    Primary: NRS pain score at 90 minutes

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    End point title
    		 NRS pain score at 90 minutes
    End point description
    End point type
    Primary
    End point timeframe
    90 minutes
    End point values
    		 Paracetamol Diclofenac Paracetamol and Diclofenac
    Number of subjects analysed
    173
    180
    175
    Units: NRS pain score
        geometric mean (confidence interval 95%)
    -1.23 (-1.50 to -0.95)
    -1.20 (-1.44 to -0.96)
    -1.18 (-1.41 to -0.94)
    Statistical analysis title
    		 Statistical analysis plan
    Statistical analysis description
    The primary outcome, between-group difference in mean NRS pain scores Unpaired numerical data conforming to a normal distribution were analyzed using one-way analysis of variance
    Comparison groups
    Paracetamol v Diclofenac v Paracetamol and Diclofenac
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0125 [1]
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [1] - Bonferroni adjustment

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none specified
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Adverse events in the ED
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events in the ED
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 547 (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
    		 Adverse events in the ED
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 547 (16.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 547 (0.91%)
         occurrences all number
    5
    Dizziness
         subjects affected / exposed
    16 / 547 (2.93%)
         occurrences all number
    16
    Tiredness
         subjects affected / exposed
    30 / 547 (5.48%)
         occurrences all number
    30
    Social circumstances
    Feeling cold
         subjects affected / exposed
    1 / 547 (0.18%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    10 / 547 (1.83%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    23 / 547 (4.20%)
         occurrences all number
    23
    Vomiting
         subjects affected / exposed
    1 / 547 (0.18%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 547 (0.18%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 547 (0.18%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Itching
         subjects affected / exposed
    2 / 547 (0.37%)
         occurrences all number
    2
    Sweating
         subjects affected / exposed
    2 / 547 (0.37%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2015
    Extension of the recruitment period

    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.
    Results regarding primary outcome available here online. For complete results, see the published manuscript in Annals of Emergency Medicine (PMID 29033294)

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29033294
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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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