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    Clinical Trial Results:
    The effect of tapentadol on the human pain system: A study based on advanced neurophysiology and imaging techniques to illustrate the mechanism of tapentadol and oxycodone in the central, autonomic and enteric nervous systems

    Summary
    EudraCT number
    		 2017-000141-52
    Trial protocol
    		 DK  
    Global end of trial date
    09 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2020
    First version publication date
    03 Dec 2020
    Other versions
    Summary report(s)
    		 Landscaping_2017 summary

    Trial information

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    Trial identification
    Sponsor protocol code
    Landscaping_2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mech-Sense
    Sponsor organisation address
    Dept. Gastroenterology & Hepatology , Aalborg, Denmark, 9000
    Public contact
    Asbjørn Mohr Drewes, Mech-Sense Dept. Gastroenterology & Hepatology Aalborg University Hospital, +45 97663524, amd@rn.dk
    Scientific contact
    Rasmus Bach Nedergaard, Mech-Sense Dept. Gastroenterology & Hepatology Aalborg University Hospital, +45 97663524, r.nedergaard@rn.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
    23 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives are to investigate the effect of tapentadol on the central, the autonomic and the enteric nervous systems.
    Protection of trial subjects
    After each ended drug administration a subjective opiate withdrawal scale (SOWS) for grading opioid withdrawal symptoms was filled in by the subject. In cases where any subject had what was classified above mild withdrawal (a total score of 11 or above) the subject was contacted and followed till they were in a mild withdrawal classification. No subjects reproted a score of 11 or above in any of the the treatment arms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2017
    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
    Denmark: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started at 16/02/2018 and ended 22/01/2019.

    Pre-assignment
    Screening details
    		 The inclusion criteria were: Male, between 20 and 45 years of age and of Scandinavian descent. The subjects were deemed to be healthy by a physician and the subjects had to be opioid naïve. There was a wash out period of 7 days between treatmet arms.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    The medication was handled, packed and delivered by the Hospital Pharmacy, Central Denmark Region, Denmark who also performed the randomization of the study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Arm title
    		 Tapentadol
    Arm description
    		 Tapentadol (Palexia®, extended release 50 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Palexia
    Investigational medicinal product code
    EMEA-000018-PIP01-07-M14
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    extended release 50 mg administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses

    Arm title
    		 Oxycodone
    Arm description
    		 Oxycodone (OxyContin®, extended release 10 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OxyContin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    extended release 10 mg administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses

    Number of subjects in period 1
    		Placebo Tapentadol Oxycodone
    Started
    22
    22
    22
    Completed
    21
    21
    21
    Not completed
    1
    1
    1
         one subject was excluded
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 22 22
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.9 ± 2.7 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Reporting group title
    Tapentadol
    Reporting group description
    		 Tapentadol (Palexia®, extended release 50 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Reporting group title
    Oxycodone
    Reporting group description
    		 Oxycodone (OxyContin®, extended release 10 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Primary: Nociceptive withdrawal reflex

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    End point title
    		 Nociceptive withdrawal reflex [1]
    End point description
    Visual analogue scale (VAS) measured at 2 times the electrical nociceptive withdrawal reflex of the foot.
    End point type
    Primary
    End point timeframe
    Baseline and end of treatment for each treatment arm
    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: The data analysis is not completed, and has not been published.
    End point values
    		 Placebo Tapentadol Oxycodone
    Number of subjects analysed
    21
    20
    20
    Units: VAS
        arithmetic mean (standard deviation)
    2.71 ± 2.12
    2.2 ± 1.4
    2.7 ± 2
    No statistical analyses for this end point

    Primary: Ice water pain perception

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    End point title
    		 Ice water pain perception [2]
    End point description
    VAS after submerging the hand in ice chilled water for 120 seconds
    End point type
    Primary
    End point timeframe
    Baseline to end of trial
    Notes
    [2] - 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: The data analysis is not completed, and has not been published.
    End point values
    		 Placebo Tapentadol Oxycodone
    Number of subjects analysed
    21
    21
    21
    Units: VAS
        arithmetic mean (standard deviation)
    5.86 ± 1.8
    5.9 ± 1.81
    5.62 ± 1.94
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16/02/2018 to 26/04/2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Questionnaire
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Reporting group title
    Tapentadol
    Reporting group description
    		 Tapentadol (Palexia®, extended release 50 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Reporting group title
    Oxycodone
    Reporting group description
    		 Oxycodone (OxyContin®, extended release 10 mg) tablets were administered orally on day 1 (after baseline measurements) and day 14 (in the morning) once, and twice a day on day 2-13 (morning and evening). In total 26 doses were administered per treatment arm.

    Serious adverse events
    		 Placebo Tapentadol Oxycodone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo Tapentadol Oxycodone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 21 (80.95%)
    18 / 21 (85.71%)
    21 / 21 (100.00%)
    Nervous system disorders
    Discomfort
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 21 (19.05%)
    10 / 21 (47.62%)
         occurrences all number
    3
    4
    10
    Dizzy
         subjects affected / exposed
    4 / 21 (19.05%)
    5 / 21 (23.81%)
    12 / 21 (57.14%)
         occurrences all number
    4
    5
    12
    Headache
         subjects affected / exposed
    4 / 21 (19.05%)
    5 / 21 (23.81%)
    9 / 21 (42.86%)
         occurrences all number
    4
    5
    9
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    9 / 21 (42.86%)
         occurrences all number
    1
    2
    9
    Tired/drowsy
         subjects affected / exposed
    9 / 21 (42.86%)
    9 / 21 (42.86%)
    18 / 21 (85.71%)
         occurrences all number
    9
    9
    18
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 21 (4.76%)
    3 / 21 (14.29%)
         occurrences all number
    4
    1
    3
    Acid reflux
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    3 / 21 (14.29%)
         occurrences all number
    1
    2
    3
    Constipation
         subjects affected / exposed
    6 / 21 (28.57%)
    6 / 21 (28.57%)
    15 / 21 (71.43%)
         occurrences all number
    6
    6
    15
    Difficulty swallowing
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    2
    Dry mouth
         subjects affected / exposed
    3 / 21 (14.29%)
    6 / 21 (28.57%)
    8 / 21 (38.10%)
         occurrences all number
    3
    6
    8
    Heartburn
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    0
    3
    Hunger pain
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 21 (19.05%)
    5 / 21 (23.81%)
         occurrences all number
    4
    4
    5
    Reduced appetite
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 21 (14.29%)
    11 / 21 (52.38%)
         occurrences all number
    2
    3
    11
    Straining during defecation
         subjects affected / exposed
    11 / 21 (52.38%)
    8 / 21 (38.10%)
    17 / 21 (80.95%)
         occurrences all number
    11
    8
    17
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 21 (14.29%)
    6 / 21 (28.57%)
         occurrences all number
    3
    3
    6

    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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