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    Clinical Trial Results:
    Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children aged from birth to less than 2 years.

    Summary
    EudraCT number
    		 2014-000623-24
    Trial protocol
    		 GB   PL  
    Global end of trial date
    03 Nov 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Oct 2017
    First version publication date
    05 May 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of the "Timeframe for reporting adverse events" definition.

    Trial information

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    Trial identification
    Sponsor protocol code
    KF5503-72
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02221674
    WHO universal trial number (UTN)
    		 U1111-1153-1662
    Other trial identifiers
    		 R331333PAI2007: Depomed Inc.
    Sponsors
    Sponsor organisation name
    Grünenthal GmbH
    Sponsor organisation address
    Zieglerstr. 6, Aachen, Germany, 52099
    Public contact
    Grünenthal Trial Information Desk, Grünenthal GmbH, 49 241569 3223, Clinical-Trials@grunenthal.com
    Scientific contact
    Grünenthal Trial Information Desk, Grünenthal GmbH, 49 241569 3223, Clinical-Trials@grunenthal.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000018-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide after the administration of a single dose of tapentadol oral solution in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain requiring opioid treatment. The concentration data will be used to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach. This will enable data based recommendations for the use of tapentadol in children of different ages in subsequent safety and efficacy trials.
    Protection of trial subjects
    The trial was conducted according to ICH-GCP guidelines, the applicable local law, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Subjects have been confined to the trial site until completion of End of Treatment assessments. This trial has been designed to protect the interests of the child subjects, including minimizing the risk to subjects and ensuring compliance with the recommendations made by an EMEA ad hoc working party (2008) regarding the amount of blood to be drawn as well as the monitoring of children in a controlled environment (post-operative setting that provides intensive monitoring).
    Background therapy
    		 During surgery and peri-operatively, the use of pre-medications, intraoperative medications, and opioid analgesics were allowed according to the usual standard of care. Non-opioid analgesics were allowed after the end of surgery/anesthesia according to medical judgment and standard of care. Medications for the treatment of adverse events were allowed according to the investigator’s judgment and post-operative standard of care
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    05 Nov 2015
    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
    Poland: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    19
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    4
    Infants and toddlers (28 days-23 months)
    15
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject signed informed consent on the 05 Nov 2014 and the last subject completed the trial on the 03 Nov 2016. The trial followed a staggered recruitment, starting with the recruitment of subjects in the oldest age group. Exposure and safety of at least 2 subjects had been assessed before enrollment in the next younger age group started.

    Pre-assignment
    Screening details
    		 The parents of a total of 40 subjects signed an informed consent and 19 of these subjects were allocated to IMP. 21 subjects dropped out before allocation to treatment: 16 subjects did not meet the inclusion and exclusion criteria, the parents of 4 subjects withdrew consent, and 1 subject was not allocated for other reasons.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Age group 1: 6 months to less than 2 years
    Arm description
    		 Infant and toddlers aged 6 months to less than 2 years at the time of allocation to IMP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol oral solution
    Investigational medicinal product code
    CG5503
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Subjects aged 6 months to less than 2 years received a dose of 0.75 mg/kg. The dose and volume has been appropriately rounded if necessary.

    Arm title
    		 Age group 2: 1 month to less than 6 months
    Arm description
    		 Infants aged 1 month to less than 6 months at the time of allocation to IMP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol oral solution
    Investigational medicinal product code
    CG5503
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Subjects aged 1 month to less than 6 months received a dose of 0.60 mg/kg. The dose and volume has been appropriately rounded if necessary.

    Arm title
    		 Age group 3: birth to less than 1 month
    Arm description
    		 Newborns and infants aged less than 1 month at the time of allocation to IMP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol oral solution
    Investigational medicinal product code
    CG5503
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Subjects from birth to less than 1 month received a dose of 0.50 mg/kg. The dose and volume has been appropriately rounded if necessary.

    Number of subjects in period 1
    		Age group 1: 6 months to less than 2 years Age group 2: 1 month to less than 6 months Age group 3: birth to less than 1 month
    Started
    8
    6
    5
    Completed
    7
    6
    5
    Not completed
    1
    0
    0
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age group 1: 6 months to less than 2 years
    Reporting group description
    		 Infant and toddlers aged 6 months to less than 2 years at the time of allocation to IMP.

    Reporting group title
    Age group 2: 1 month to less than 6 months
    Reporting group description
    		 Infants aged 1 month to less than 6 months at the time of allocation to IMP.

    Reporting group title
    Age group 3: birth to less than 1 month
    Reporting group description
    		 Newborns and infants aged less than 1 month at the time of allocation to IMP.

    Reporting group values
    		 Age group 1: 6 months to less than 2 years Age group 2: 1 month to less than 6 months Age group 3: birth to less than 1 month Total
    Number of subjects
    		 8 6 5 19
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 420 ( 147.8 ) 92.8 ( 37.9 ) 14.6 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 2 3 9
        Male
    		 4 4 2 10
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    		 73.3 ( 5.2 ) 62 ( 4.3 ) 53.4 ( 4.4 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 9.21 ( 1.5 ) 5.92 ( 1.18 ) 3.78 ( 0.66 ) -
    Body Mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 17.11 ( 1.36 ) 15.28 ( 1.31 ) 13.36 ( 2.49 ) -

    End points

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    End points reporting groups
    Reporting group title
    Age group 1: 6 months to less than 2 years
    Reporting group description
    		 Infant and toddlers aged 6 months to less than 2 years at the time of allocation to IMP.

    Reporting group title
    Age group 2: 1 month to less than 6 months
    Reporting group description
    		 Infants aged 1 month to less than 6 months at the time of allocation to IMP.

    Reporting group title
    Age group 3: birth to less than 1 month
    Reporting group description
    		 Newborns and infants aged less than 1 month at the time of allocation to IMP.

    Subject analysis set title
    Age group 1_ Pharmacokinetic Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects of age group 1 who had quantifiable serum concentrations.

    Subject analysis set title
    Age group 2_ Pharmacokinetic Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects of age group 2 who had quantifiable serum concentrations.

    Subject analysis set title
    Age group 3_ Pharmacokinetic Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects of age group 3 who had quantifiable serum concentrations.

    Primary: Age group 1: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 1: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution [1]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 1_ Pharmacokinetic Set
    Number of subjects analysed
    7 [2]
    Units: nanogram(s)/milliliter
    arithmetic mean (standard deviation)
        30 minutes after administration (N=3)
    9.8 ( 5.21 )
        1 hour after administration (N=1)
    18.79 ( 0 )
        2 hours after administration (N=2)
    32.2 ( 14.92 )
        4 hours after administration (N=3)
    11.1 ( 5.97 )
        6 hours after administration (N=1)
    14.85 ( 0 )
        8 hours after administration (N=2)
    10.7 ( 4.15 )
    Notes
    [2] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Primary: Age group 2: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 2: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution [3]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    Notes
    [3] - 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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 2_ Pharmacokinetic Set
    Number of subjects analysed
    6 [4]
    Units: nanogram(s)/mililitre
    arithmetic mean (standard deviation)
        30 minutes after administration (N=2)
    8.3 ( 6.3 )
        1 hour after administration (N=1)
    35.27 ( 0 )
        2 hours after administration (N=3)
    27.3 ( 0.81 )
        4 hours after administration (N=2)
    25.9 ( 10.33 )
        6 hours after administration (N=1)
    32.75 ( 0 )
        8 hours after administration (N=2)
    5.6 ( 1.81 )
    Notes
    [4] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Primary: Age group 3: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 3: Pharmacokinetic Profile of Serum Concentrations of Tapentadol after a Single Dose of Tapentadol Oral Solution [5]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    Notes
    [5] - 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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 3_ Pharmacokinetic Set
    Number of subjects analysed
    5 [6]
    Units: nanogram(s)/millilitre
    arithmetic mean (standard deviation)
        30 minutes after administration (N=1)
    26.62 ( 0 )
        1 hour after administration (N=1)
    43.63 ( 0 )
        2 hours after administration (N=2)
    19.9 ( 7.67 )
        4 hours after administration (N=2)
    15 ( 8.92 )
        6 hours after administration (N=1)
    18.82 ( 0 )
        8 hours after administration (N=2)
    14.6 ( 6.26 )
    Notes
    [6] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Primary: Age group 1: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 1: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution [7]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    Notes
    [7] - 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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 1_ Pharmacokinetic Set
    Number of subjects analysed
    7 [8]
    Units: nanogram(s)/millilitre
    arithmetic mean (standard deviation)
        30 minutes after administration (N=3)
    105.7 ( 125 )
        1 hour after administration (N=1)
    430.7 ( 0 )
        2 hours after administration (N=2)
    468 ( 248.41 )
        4 hours after administration (N=3)
    348.7 ( 228.22 )
        6 hours after administration (N=1)
    370.2 ( 0 )
        8 hours after administration (N=2)
    285.1 ( 107.06 )
    Notes
    [8] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Primary: Age group 2: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 2: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution [9]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    Notes
    [9] - 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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 2_ Pharmacokinetic Set
    Number of subjects analysed
    6 [10]
    Units: nanogram(s)/millilitre
    arithmetic mean (standard deviation)
        30 minutes after administration (N=1)
    128.8 ( 0 )
        1 hour after administration (N=1)
    136.3 ( 0 )
        2 hours after administration (N=3)
    324.9 ( 116.61 )
        4 hours after administration (N=2)
    449.7 ( 7.42 )
        6 hours after administration (N=1)
    253.3 ( 0 )
        8 hours after administration (N=2)
    92.2 ( 63.83 )
    Notes
    [10] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Primary: Age group 3: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution

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    End point title
    		 Age group 3: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide after a Single Dose of Tapentadol Oral Solution [11]
    End point description
    Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Concentrations were determined using validated liquid chromatography-tandem mass spectrometry bioanalytical assays.
    End point type
    Primary
    End point timeframe
    Up to 8 hours after IMP administration at two time points per subject.
    Notes
    [11] - 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 primary objective of the trial was to collect serum concentration data of tapentadol and its major metabolite tapentadol-O-glucuronide to characterize the pharmacokinetic parameters of tapentadol using a population and physiologically-based pharmacokinetic approach.
    End point values
    		 Age group 3_ Pharmacokinetic Set
    Number of subjects analysed
    5 [12]
    Units: nanogram(s)/millilitre
    arithmetic mean (standard deviation)
        30 minutes after administration (N=1)
    74.38 ( 0 )
        1 hour after administration (N=1)
    209 ( 0 )
        2 hours after administration (N=2)
    98.5 ( 2.62 )
        4 hours after administration (N=2)
    147.6 ( 53.74 )
        6 hours after administration (N=1)
    224.8 ( 0 )
        8 hours after administration (N=2)
    174.1 ( 11.03 )
    Notes
    [12] - Summary statistics were only calculated when there were 2 or more samples.
    No statistical analyses for this end point

    Secondary: Change in pain intensity using the Face, Legs, Activity, Cry, Consolability scale (FLACC)

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    End point title
    		 Change in pain intensity using the Face, Legs, Activity, Cry, Consolability scale (FLACC)
    End point description
    The change from baseline in pain intensity using the Face, Legs, Activity, Cry, Consolability Scale (FLACC Scale) at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after dosing with tapentadol. The FLACC Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. It is a behavioral scale for scoring postoperative pain in young children. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten.
    End point type
    Secondary
    End point timeframe
    Predose, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after dosing with tapentadol.
    End point values
    		 Age group 1: 6 months to less than 2 years Age group 2: 1 month to less than 6 months Age group 3: birth to less than 1 month
    Number of subjects analysed
    8 [13]
    6
    5
    Units: units on a scale
    arithmetic mean (standard deviation)
        + 15 min
    -0.8 ( 3.1 )
    -1.3 ( 2.8 )
    -1.6 ( 1.5 )
        + 30 min
    -1.1 ( 2.6 )
    -3 ( 3.6 )
    -1.4 ( 1.5 )
        + 1 hour
    -2 ( 3.6 )
    -2.7 ( 4.5 )
    0 ( 3.7 )
        + 2 hours
    -2.8 ( 2.9 )
    -3 ( 3.9 )
    -0.4 ( 2.6 )
        + 4 hours
    -1.6 ( 3.4 )
    -2.2 ( 3.3 )
    -0.4 ( 2.3 )
        + 6 hours
    -1.9 ( 3.1 )
    -1.7 ( 4.8 )
    -0.4 ( 2.3 )
        + 8 hours
    -2.5 ( 2.5 )
    -3 ( 3.2 )
    -1.2 ( 1.1 )
        + 12 hours
    -2.4 ( 2.8 )
    -3.5 ( 3.8 )
    -1.4 ( 1.5 )
        + 15 hours
    -2.1 ( 3.5 )
    -3.8 ( 3.9 )
    -1 ( 2.1 )
    Notes
    [13] - For the timepoint "+ 6 hours" only 7 values were collected.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any Adverse Events that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened after IMP administration intake have been recorded as a new AE.
    Adverse event reporting additional description
    The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Age group 1: 6 months to less than 2 years
    Reporting group description
    		 Infant and toddlers aged 6 months to less than 2 years at the time of allocation to IMP.

    Reporting group title
    Age group 2: 1 month to less than 6 months
    Reporting group description
    		 Infants aged 1 month to less than 6 months at the time of allocation to IMP.

    Reporting group title
    Age group 3: birth to less than 1 month
    Reporting group description
    		 Newborns and infants aged less than 1 month at the time of allocation to IMP.

    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Age group 1: 6 months to less than 2 years Age group 2: 1 month to less than 6 months Age group 3: birth to less than 1 month Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Age group 1: 6 months to less than 2 years Age group 2: 1 month to less than 6 months Age group 3: birth to less than 1 month Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    8 / 19 (42.11%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    3
    3
    Injury, poisoning and procedural complications
    Stoma site erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    1
    Wound dehiscence
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    1
    Cardiac disorders
    Junctional ectopic tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    2
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Tachypnoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2015
    Adapted inclusion and exclusion criteria and certain study procedures to better align with the "standard of care" procedures.

    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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