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    Clinical Trial Results:
    Treatment of acute locomotoric pain in the geriatric patient: comparison of effectiveness and safety between step 2 (weak opioids) and step 3 (strong opioids) pain relief of the WHO-ladder.

    Summary
    EudraCT number
    		 2016-002379-89
    Trial protocol
    		 BE  
    Global end of trial date
    06 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Aug 2024
    First version publication date
    08 Aug 2024
    Other versions
    Summary report(s)
    		 manuscript
    full data set
    Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2016/007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
    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
    06 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether there is a difference in effectiveness and safety between two commonly used therapeutic strategies: step 2 versus step 3 of the WHO pain ladder.
    Protection of trial subjects
    treatment was based upon good clinical practice adverse events were monitored and therapy was stopped if necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2016
    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
    Belgium: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    0
    From 65 to 84 years
    25
    85 years and over
    24

    Subject disposition

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    Recruitment
    Recruitment details
    		 See attachment Final Study Report

    Pre-assignment
    Screening details
    		 70 years or older, admitted to the acute geriatric ward and suffering from acute (less than 72 hours) moderate to severe (numeric rating scale (NRS) ≥ 5) locomotor pain on at least one moment on the day of inclusion

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 oxycodone group
    Arm description
    		 patients treated with strong opioids
    Arm type
    		 Active comparator

    Investigational medicinal product name
    oxycodone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    oxycodone extended release (ER) 5mg twice a day, with oxycodone instant release (IR) 5mg as rescue medication in case of breakthrough pain, with a maximum of six times a day

    Arm title
    		 tramadol group
    Arm description
    		 patients treated with weak opioids
    Arm type
    		 Active comparator

    Investigational medicinal product name
    tramadol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    tramadol extended release (ER) 50mg twice a day, with tramadol instant release (IR) 50mg as rescue medication in case of breakthrough pain, with a maximum of four times a day

    Number of subjects in period 1
    		oxycodone group tramadol group
    Started
    24
    25
    Completed
    24
    25

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    oxycodone group
    Reporting group description
    		 patients treated with strong opioids

    Reporting group title
    tramadol group
    Reporting group description
    		 patients treated with weak opioids

    Primary: effect on pain

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    End point title
    		 effect on pain
    End point description
    effect on pain, measured by NRS
    End point type
    Primary
    End point timeframe
    7 days
    End point values
    		 oxycodone group tramadol group
    Number of subjects analysed
    24
    25
    Units: NRS
        number (not applicable)
    24
    25
    Statistical analysis title
    		 effect on pain
    Comparison groups
    oxycodone group v tramadol group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    daily
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 naranjo
    Dictionary version
    1
    Reporting groups
    Reporting group title
    tramadol group
    Reporting group description
    		 -

    Serious adverse events
    		 tramadol group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    		 tramadol group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    Nervous system disorders
    Convulsions local
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    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
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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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