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    Clinical Trial Results:
    A Randomized Open Label Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function after Colorectal Surgery

    Summary
    EudraCT number
    		 2013-005327-16
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2020
    First version publication date
    29 Jul 2020
    Other versions
    Summary report(s)
    		 Targinact

    Trial information

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    Trial identification
    Sponsor protocol code
    NA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02109640
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clintrials.gov Number: NCT02109640, REC Number: 14/ES/0016
    Sponsors
    Sponsor organisation name
    University of Edinburgh & NHS Lothian
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Hugh Paterson, University of Edinburgh, 07780 957402, hugh.paterson@ed.ac.uk
    Scientific contact
    Hugh Paterson, University of Edinburgh, 07780 957402, hugh.paterson@ed.ac.uk
    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
    01 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare Targinact (prolonged release naloxone + oxycodone) with current standard treatment (oxycodone alone) in post-operative return of normal gut function after elective colorectal resectional surgery.
    Protection of trial subjects
    As with all opioid analgesics, there is a risk of side effects. Initial doses of the study drug were given in hospital under regular monitoring of observations as per normal practice in post-operative patients. Participants discharged on study drug were counselled on the risks of opioid analgesics as per normal practice and advised to discontinue use at the earliest opportunity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Dec 2014
    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
    United Kingdom: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    14
    From 65 to 84 years
    46
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled for elective laparoscopic segmental colonic resection in a single colorectal surgery unit were recruited by study staff during scheduled preoperative visits.

    Pre-assignment
    Screening details
    		 Patients scheduled for elective laparoscopic segmental colonic resection in a single colorectal surgery unit were screened for eligibility. 82 patients were assessed for eligibility. 20 of these were excluded: did not meet inclusion criteria n = 16; declined to participate n = 2; other reason n = 2. 62 patients were recruited.

    Period 1
    Period 1 title
    Whole study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The statistician was blinded to which group was allocated to intervention and which to control.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oxycodone
    Arm description
    		 Post-op analgesia based on modified release oxycodone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxycodone
    Investigational medicinal product code
    PL 16950/0097-0100,0123,0139-0141, 0150
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-20mgd bd

    Arm title
    		 Targinact
    Arm description
    		 Intervention arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Targinact
    Investigational medicinal product code
    PRD506871
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-20mg bd

    Number of subjects in period 1
    		Oxycodone Targinact
    Started
    30
    32
    Completed
    23
    27
    Not completed
    7
    5
         Physician decision
    1
    2
         Conversion to open surgery
    2
    1
         Ineligibility
    3
    2
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oxycodone
    Reporting group description
    		 Post-op analgesia based on modified release oxycodone

    Reporting group title
    Targinact
    Reporting group description
    		 Intervention arm

    Reporting group values
    		 Oxycodone Targinact Total
    Number of subjects
    		 30 32 62
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 7 13
        From 65-84 years
    		 16 19 35
        85 years and over
    		 1 1 2
        Excluded from analysis
    		 7 5 12
    Age continuous
    Units: years
        median (full range (min-max))
    		 68 (50 to 87) 71 (30 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12 24
        Male
    		 11 15 26
        Not recorded
    		 7 5 12
    Type of operation
    Right or left colectomy
    Units: Subjects
        Right colectomy
    		 10 14 24
        Left colectomy
    		 13 13 26
        Excluded from analysis
    		 7 5 12
    Subject analysis sets

    Subject analysis set title
    Subjects receiving the intervention/control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Analyses of the data included Fisher’s exact test for categorical data (owing to the small numbers in some of the cells), and Student’s t test, with log transformation where appropriate. Estimates of differences in proportions and means were also calculated. The randomized groups were compared for a number of clinical measures, and in general a comment is made where there was little or no difference between the groups. All of the analyses are descriptive, no adjustment was made for multiple comparisons. A two-sided 5 per cent significance level was applied throughout. Participant data was anonymised prior to analysis and the analysis was conducted by an independent statistician who was blinded to the treatment.

    Subject analysis sets values
    		 Subjects receiving the intervention/control
    Number of subjects
    50
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    13
        From 65-84 years
    35
        85 years and over
    2
        Excluded from analysis
    12
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    24
        Male
    26
        Not recorded
    12
    Type of operation
    Right or left colectomy
    Units: Subjects
        Right colectomy
    24
        Left colectomy
    26
        Excluded from analysis
    12

    End points

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    End points reporting groups
    Reporting group title
    Oxycodone
    Reporting group description
    		 Post-op analgesia based on modified release oxycodone

    Reporting group title
    Targinact
    Reporting group description
    		 Intervention arm

    Subject analysis set title
    Subjects receiving the intervention/control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Analyses of the data included Fisher’s exact test for categorical data (owing to the small numbers in some of the cells), and Student’s t test, with log transformation where appropriate. Estimates of differences in proportions and means were also calculated. The randomized groups were compared for a number of clinical measures, and in general a comment is made where there was little or no difference between the groups. All of the analyses are descriptive, no adjustment was made for multiple comparisons. A two-sided 5 per cent significance level was applied throughout. Participant data was anonymised prior to analysis and the analysis was conducted by an independent statistician who was blinded to the treatment.

    Primary: Return of postoperative gut function

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    End point title
    		 Return of postoperative gut function
    End point description
    Post-operative at which composite of the following achieved: tolerating oral diet; passage of flatus/faeces/minimal nausea and vomiting
    End point type
    Primary
    End point timeframe
    Assessed on postoperative day 3
    End point values
    		 Oxycodone Targinact
    Number of subjects analysed
    23
    27
    Units: number
    number (not applicable)
        Day 3
    15
    13
        Day 4
    17
    23
    Attachments
    		 Postoperative day of return of gut function
    Statistical analysis title
    		 Return of gut function day 3
    Comparison groups
    Oxycodone v Targinact
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.264 [1]
    Method
    		 Fisher exact
    Parameter type
    		 Absolute % difference
    Point estimate
    17.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 40.7
    Notes
    [1] - unadjusted

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days after operation
    Adverse event reporting additional description
    Normal postoperative events such as mild nausea, pain etc excluded a priori
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Complications
    Reporting group description
    		 There were two major complications in the intervention arm of the study: one intra-abdominal collection was drained percutaneously and one (day 4) anastomotic dehiscence required reoperation, repair and proximal diversion. There were no major complications in the control arm.

    Serious adverse events
    		 Complications
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Complications
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2014
    Change of study design from double-blinded to open label blinded design. Addition of a novel method of documenting nutritional intake (Digital Photography of Food Method). Addition of postoperative in-patient activity monitoring.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27762434
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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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