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    Clinical Trial Results:
    Perioperative administration of Tapentadol – tolerance, safety and effects on postoperative rehabilitation and quality of life. Randomized, controlled study to compare the analgesic therapy with tapentadol compared to pure opioid receptor agonists

    Summary
    EudraCT number
    		 2012-004585-18
    Trial protocol
    		 DE  
    Global end of trial date
    21 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions
    Summary report(s)
    		 PATENT_E3 synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    KKS-190
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trials Register: DRKS00005432
    Sponsors
    Sponsor organisation name
    Philipps-Universität Marburg
    Sponsor organisation address
    Biegenstr. 10, Marburg, Germany, 35037
    Public contact
    Koordinierungszentrum für Klinische Studien (KKS) Marburg, Philipps-Universität Marburg, 0049 642128 66509, info@kks.uni-marburg.de
    Scientific contact
    Koordinierungszentrum für Klinische Studien (KKS) Marburg, Philipps-Universität Marburg, 0049 642128 66509, info@kks.uni-marburg.de
    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
    21 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Simplified PONV Impact Scale Score [Wengritzky 2012]
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 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
    Germany: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    110
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1. Medical anamnesis 2. Documentation of the premedication 3. Vital signs 4. Risk score for the occurrence of nausea and vomiting in the postoperative phase (apple score) 5. Assessment of health-related quality of life (SF-12 questionnaire).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tapentadol Palexia
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol Palexia @
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Other use
    Dosage and administration details
    Prior surgery: routine anxiolytic (midazolam) + Tapentadol Palexia@ retard 200 mg + 90 mg Etoricoxib. After surgery: 60 mg Etoricoxib + Tapentadol Palexia. Postoperatively, the investigational drug Palexia@ 50 mg film-coated tablets (unretarded tapentadol:) can also be taken every 30 minutes for moderate or severe pain (NRS score ≥ 4) as an analgesic indication of need. After a 12-hour observation interval, the next basic medication with Palexia® retard is administered using an adaptive dosing algorithm depending on the tapentadol dose/opioid dose requested in the previous dosing interval (analgesic medication on demand + rescue medication).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Standard Therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prior surgery: routine anxiolytic (midazolam) + 90 mg Etoricoxib. After surgery: 60 mg Etoricoxib.

    Number of subjects in period 1
    		Tapentadol Palexia Placebo
    Started
    60
    60
    Completed
    56
    59
    Not completed
    4
    1
         Consent withdrawn by subject
    2
    1
         Did not undergo surgery
    1
    -
         received peridural anesthesia
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tapentadol Palexia
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Tapentadol Palexia Placebo Total
    Number of subjects
    		 60 60 120
    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
        median (full range (min-max))
    		 50 (27 to 78) 48 (35 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 60 60 120
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Tapentadol Palexia
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Simplified PONV Impact Scale Score [Wengritzky 2012]

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    End point title
    		 Simplified PONV Impact Scale Score [Wengritzky 2012]
    End point description
    End point type
    Primary
    End point timeframe
    24 hour postoperative
    End point values
    		 Tapentadol Palexia Placebo
    Number of subjects analysed
    56
    59
    Units: Score
        arithmetic mean (standard deviation)
    15.9 ( 28.7 )
    9.7 ( 26.6 )
    Statistical analysis title
    		 AUC
    Statistical analysis description
    AUC for cumulative simplified PONV Impacat scale score over 48 hours postoperative.
    Comparison groups
    Tapentadol Palexia v Placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0975
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time between the date of informed consent and 30 days after the last administration of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tapentadol Palexia
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tapentadol Palexia Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tapentadol Palexia Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 56 (92.86%)
    46 / 59 (77.97%)
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    2 / 56 (3.57%)
    7 / 59 (11.86%)
         occurrences all number
    2
    7
    Hypotension
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Circulatory collapse
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Hot flush
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 59 (5.08%)
         occurrences all number
    4
    3
    Oedema peripheral
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 59 (5.08%)
         occurrences all number
    3
    3
    Chest pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Vaginal haematoma
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    11 / 56 (19.64%)
    3 / 59 (5.08%)
         occurrences all number
    11
    3
    Oropharyngeal pain
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 59 (1.69%)
         occurrences all number
    3
    1
    Dyspnoea
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    6 / 56 (10.71%)
    6 / 59 (10.17%)
         occurrences all number
    6
    6
    depressive s
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    Disorientation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Blood urine present
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Procedural hypotension
         subjects affected / exposed
    21 / 56 (37.50%)
    21 / 59 (35.59%)
         occurrences all number
    21
    21
    Procedural vomiting
         subjects affected / exposed
    8 / 56 (14.29%)
    6 / 59 (10.17%)
         occurrences all number
    8
    6
    Procedural nausea
         subjects affected / exposed
    6 / 56 (10.71%)
    2 / 59 (3.39%)
         occurrences all number
    2
    2
    Procedural pain
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 59 (6.78%)
         occurrences all number
    2
    4
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 59 (6.78%)
         occurrences all number
    0
    4
    Procedural complication
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Procedural hypertension
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Post procedural complication
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Wound haematoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Wound haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Wound secretion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    Bradycardia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Extrasystoles
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 59 (5.08%)
         occurrences all number
    1
    3
    Dizziness
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 59 (0.00%)
         occurrences all number
    3
    0
    sensory
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 59 (5.08%)
         occurrences all number
    1
    3
    Leukocytosis
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    9 / 56 (16.07%)
    10 / 59 (16.95%)
         occurrences all number
    9
    10
    Constipation
         subjects affected / exposed
    10 / 56 (17.86%)
    6 / 59 (10.17%)
         occurrences all number
    10
    6
    Nausea
         subjects affected / exposed
    7 / 56 (12.50%)
    1 / 59 (1.69%)
         occurrences all number
    7
    1
    Vomiting
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    Abdominal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 59 (6.78%)
         occurrences all number
    2
    4
    Musculoskeletal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Infections and infestations
    Blood glucose abnormal
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Nosocomial infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 59 (5.08%)
         occurrences all number
    1
    3
    Acidosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2015
    Indication: Reduction to one indication (hysterectomy), thus stratification at randomization was also omitted. The planned number of patients was reduced from 150 to 120. The ECG before surgery was omitted due to complex surgical hygiene.

    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
    For support, Contact us.
    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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