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    Clinical Trial Results:
    Safety and Efficacy of Patient Controlled Analgesia using the Sublingual Sufentanil Tablet System (SSTS) in a fast track rehabilitation program after Total Knee Arthroplasty.

    Summary
    EudraCT number
    		 2019-001232-59
    Trial protocol
    		 BE  
    Global end of trial date
    19 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2024
    First version publication date
    07 Jun 2024
    Other versions
    Summary report(s)
    		 Protocol
    Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2019/002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    HIRUZ CTU, Ghent University Hospital, +32 93320500, Hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ CTU, Ghent University Hospital, 093320000 93320500, Hiruz.ctu@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
    16 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficiency of Sublingual Sufentanil Tablet System (SSTS) which is defined as 75% or more of the treated patients proves NRS less than 4 during 48 hours postoperatively, additionally to the basic pain treatment (paracetamol and NSAID).
    Protection of trial subjects
    See attachments
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2020
    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
    Belgium: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    55
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 See attachments

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

    Arms
    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zalviso
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Start administration medication at request of the patient or NRS≥4 T0 : 20 minutes after first use of PCA STSS at PACU Stop administration medication : at 48 hours postoperatively, for comfort reasons it can be continued until 72 hours postoperatively

    Number of subjects in period 1
    		Arm A
    Started
    90
    Completed
    90

    Baseline characteristics

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

    Reporting group values
    		 Period Total
    Number of subjects
    		 90 90
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 55 55
        85 years and over
    		 35 35
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 46 46

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Primary: Main

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    End point title
    		 Main [1]
    End point description
    End point type
    Primary
    End point timeframe
    Cumulative/total time when NRS<4 during 48 hours postoperatively – after 48 hours postoperatively Length of hospital stay – after the patient discharge Nausea, vomiting, itching, drowsiness, constipation, desaturation – up to 72 hours postoperatively E
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attachments
    End point values
    		 Arm A
    Number of subjects analysed
    90
    Units: Subjects
    90
    No statistical analyses for this end point

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    End point type
    Secondary
    End point timeframe
    Cumulative/total time when NRS<4 during 48 hours postoperatively – after 48 hours postoperatively Length of hospital stay – after the patient discharge Nausea, vomiting, itching, drowsiness, constipation, desaturation – up to 72 hours postoperatively E
    End point values
    		 Arm A
    Number of subjects analysed
    90
    Units: Subjects
    90
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: See attachments

    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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