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    Clinical Trial Results:
    A novel approach to assess gastrointestinal adverse effects of opioids

    Summary
    EudraCT number
    		 2013-001540-60
    Trial protocol
    		 DK  
    Global end of trial date
    26 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MULTIPAIN6-2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aalborg University Hospital
    Sponsor organisation address
    Mølleparkvej 4, Aalborg, Denmark, 9000
    Public contact
    Dept. Gastroenterology & Hepatology, Mech-Sense, Aalborg University Hospital, 45 99326243,
    Scientific contact
    Dept. Gastroenterology & Hepatology, Mech-Sense, Aalborg University Hospital, 45 99326243,
    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
    Interim
    Date of interim/final analysis
    05 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to develop and validate a model capable of assessing gastrointestinal adverse effects of opioid treatment: opioid induced bowel dysfunction (OIBD) in healthy volunteers (substudy 1a and 1b).
    Protection of trial subjects
    Daily inquiries during the study periods aimed at detecting any positive/euphoric experiences from the study medication. If so, the subject was withdrawn from the study immediately. All subjects were also required to fill out a Subjective Opiate Withdrawal Scale (SOWS) questionnaire three days after receiving the last dose in all study periods to monitor whether any degree of dependence had developed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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
    Denmark: 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)
    50
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers will be recruited through an already established database and posters and flyers distributed and hung at the Aalborg University Hospital and Aalborg University. Chronic pancreatitis patients will be recruited from Aalborg University Hospital, Outpatient Clinic for chronic pancreatitis

    Pre-assignment
    Screening details
    		 Following informed consent, the subjects undervent a screening session. A medical doctor examined the subject, and they were screened to fulfil all inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Substudy 1b
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Substudy 1b_Oxycodone arm
    Arm description
    		 Substudy 1b_Oxycodone arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    OxyContin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 to 10 milligrams (mg) twice daily

    Arm title
    		 Substudy 1b_Placebo arm
    Arm description
    		 Substudy 1b_Placebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets for OxyCodone

    Number of subjects in period 1
    		Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm
    Started
    25
    25
    Completed
    25
    25
    Period 2
    Period 2 title
    Substudy 2a
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Substudy 2a_OxyContin+Movicol arm
    Arm description
    		 Substudy 2a_OxyContin+Movicol arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    OxyContin+Movicol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder, Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    OxyContin 5 to 10 mg twice daily + Movicol(macrogol 3350) 1 sachet (13,125 g) twice daily

    Arm title
    		 Substudy 2a_Targin+Placebo for Movicol arm
    Arm description
    		 Substudy 2a_Targin+Placebo for Movicol arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Targin+Placebo for Movicol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder, Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Targin (Oxycodon/naloxone) 5/2,5 to 10/5 mg twice daily + Placebo powder for Movicol (macrogol 3350) 1 sachet (13,125 g) twice daily

    Number of subjects in period 2
    		Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Started
    20
    20
    Completed
    20
    20
    Period 3
    Period 3 title
    Substudy 2b
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Substudy 2b_Chronic Pancreatitis
    Arm description
    		 Substudy 2b_Chronic Pancreatitis - exploratory study in patients suffering from chronic pancreatitis.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Substudy 2b_Chronic Pancreatitis
    Started
    28
    Completed
    28

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Substudy 1b
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: As this trial included three substudies, not all subjects participated in the baseline period (period 1/substudy 1b)
    Reporting group values
    		 Substudy 1b Total
    Number of subjects
    		 25 25
    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)
    		 25 25
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Substudy 1b_Oxycodone arm
    Reporting group description
    		 Substudy 1b_Oxycodone arm

    Reporting group title
    Substudy 1b_Placebo arm
    Reporting group description
    		 Substudy 1b_Placebo arm
    Reporting group title
    Substudy 2a_OxyContin+Movicol arm
    Reporting group description
    		 Substudy 2a_OxyContin+Movicol arm

    Reporting group title
    Substudy 2a_Targin+Placebo for Movicol arm
    Reporting group description
    		 Substudy 2a_Targin+Placebo for Movicol arm
    Reporting group title
    Substudy 2b_Chronic Pancreatitis
    Reporting group description
    		 Substudy 2b_Chronic Pancreatitis - exploratory study in patients suffering from chronic pancreatitis.

    Primary: Gastric emptying

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    End point title
    		 Gastric emptying
    End point description
    End point type
    Primary
    End point timeframe
    For each arm in period 1 and 2 and 3 (NB! Only one arm in period 3)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm Substudy 2b_Chronic Pancreatitis
    Number of subjects analysed
    0 [1]
    0 [2]
    19
    19
    0 [3]
    Units: hour
        median (inter-quartile range (Q1-Q3))
    ( to )
    ( to )
    3.2 (2.3 to 4.9)
    3.5 (2.6 to 6.8)
    ( to )
    Notes
    [1] - Not possible to evaluate gastric emptying for this substudy due to technical issues.
    [2] - Not possible to evaluate gastric emptying for this substudy due to technical issues.
    [3] - Data yet to be analysed for this substudy
    Statistical analysis title
    		 Comparison of transit time between treatments
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.334
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Small intestinal transit

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    End point title
    		 Small intestinal transit
    End point description
    End point type
    Primary
    End point timeframe
    For each arm in period 1 and 2 and 3 (NB! Only one arm in period 3)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm Substudy 2b_Chronic Pancreatitis
    Number of subjects analysed
    19
    19
    19
    19
    0 [4]
    Units: hour
        median (inter-quartile range (Q1-Q3))
    5.3 (1.5 to 9.6)
    3.7 (1.9 to 10.0)
    5.8 (4.6 to 8.1)
    5.3 (4.7 to 6.3)
    ( to )
    Notes
    [4] - Data yet to be analysed
    Statistical analysis title
    		 Comparison of transit time between treatments
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.147
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison of transit time between treatments
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.091
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Colorectal transit time

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    End point title
    		 Colorectal transit time
    End point description
    End point type
    Primary
    End point timeframe
    For each arm in period 1 and 2 and 3 (NB! Only one arm in period 3)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm Substudy 2b_Chronic Pancreatitis
    Number of subjects analysed
    19
    19
    19
    19
    0 [5]
    Units: hour
        median (inter-quartile range (Q1-Q3))
    38.6 (5.6 to 88.6)
    18.6 (7.0 to 82.2)
    38.2 (30.9 to 61.2)
    39.6 (26.6 to 74.3)
    ( to )
    Notes
    [5] - Data yet to be analysed
    Statistical analysis title
    		 Comparison of transit time between treatments
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison of transit time between treatments
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.872
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in fecal volume ascending colon (day 5-baseline)

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    End point title
    		 Change in fecal volume ascending colon (day 5-baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 and 2 (This endpoint was only assessed in healthy volunteers and thus NOT a part of substudy 3/period 3 in chronic pancreatitis patients)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects analysed
    18
    18
    12
    12
    Units: millilitre(s)
        arithmetic mean (confidence interval 95%)
    77 (29 to 124)
    49 (17 to 81)
    54 (23 to 85)
    26 (1 to 51)
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    P-value
    		 = 0.005
    Method
    		 ANOVA
    Confidence interval
    Notes
    [6] - Test if significant change in fecal volume from day 1 to day 5 within same period/treatment
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.03
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_Targin+Placebo for Movicol arm v Substudy 2a_OxyContin+Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.156
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in fecal volume transverse colon (day 5-baseline)

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    End point title
    		 Change in fecal volume transverse colon (day 5-baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 and 2 (This endpoint was only assessed in healthy volunteers and thus NOT a part of substudy 3/period 3 in chronic pancreatitis patients)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects analysed
    18
    18
    12
    12
    Units: millilitre(s)
        arithmetic mean (confidence interval 95%)
    49 (17 to 81)
    -6 (-28 to 16)
    87 (40 to 134)
    48 (11 to 85)
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.005
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.57
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_Targin+Placebo for Movicol arm v Substudy 2a_OxyContin+Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.161
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in fecal volume descending colon (day 5-baseline)

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    End point title
    		 Change in fecal volume descending colon (day 5-baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 and 2 (This endpoint was only assessed in healthy volunteers and thus NOT a part of substudy 3/period 3 in chronic pancreatitis patients)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects analysed
    18
    18
    12
    12
    Units: millilitre(s)
        arithmetic mean (confidence interval 95%)
    25 (3 to 47)
    -12 (-24 to 0)
    70 (35 to 105)
    38 (0 to 76)
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.08
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.07
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.022
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Change in fecal volume from day 1 to day 5
    Comparison groups
    Substudy 2a_Targin+Placebo for Movicol arm v Substudy 2a_OxyContin+Movicol arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.384
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Sphincter function (FLIP)

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    End point title
    		 Sphincter function (FLIP)
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 and 2 (This endpoint was only assessed in healthy volunteers and thus NOT a part of substudy 3/period 3 in chronic pancreatitis patients)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects analysed
    25
    25
    20
    20
    Units: pressure-strain elastic modulus
        number (not applicable)
    3
    4
    6
    6
    Statistical analysis title
    		 Change in anal canal distensibility
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Change in anal canal distensibility
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Gut secretion - short circuit current

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    End point title
    		 Gut secretion - short circuit current
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 (This endpoint was ONLY evaluated in healthy volunteers in period 1, and due to the results during period 1/substudy 1b this endpoint was dropped in period 2 and 3, substudy 2a and 2b, respectively)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm
    Number of subjects analysed
    25
    25
    Units: microampere per sqauare centimeter
        arithmetic mean (confidence interval 95%)
    12 (9 to 15)
    7 (5 to 9)
    Statistical analysis title
    		 Change in SCC from day 1 to day 5
    Comparison groups
    Substudy 1b_Oxycodone arm v Substudy 1b_Placebo arm
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.78
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Change in SCC from day 1 to day 5
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.47
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Subjective assessment - Bowel Function Index

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    End point title
    		 Subjective assessment - Bowel Function Index
    End point description
    End point type
    Secondary
    End point timeframe
    For each arm in period 1 and 2 (This endpoint was only assessed in healthy volunteers and thus NOT a part of substudy 3/period 3 in chronic pancreatitis patients)
    End point values
    		 Substudy 1b_Oxycodone arm Substudy 1b_Placebo arm Substudy 2a_OxyContin+Movicol arm Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects analysed
    25
    25
    20
    20
    Units: score
    34
    3
    23
    22
    Statistical analysis title
    		 Change in BFI score between treatments
    Comparison groups
    Substudy 1b_Placebo arm v Substudy 1b_Oxycodone arm
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Change in BFI score between treatments
    Comparison groups
    Substudy 2a_OxyContin+Movicol arm v Substudy 2a_Targin+Placebo for Movicol arm
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.666
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2013-08-08 to 2017-09-26
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Period 1, 2 and 3 (all study periods)
    Reporting group description
    		 -

    Serious adverse events
    		 Period 1, 2 and 3 (all study periods)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Period 1, 2 and 3 (all study periods)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 25 (28.00%)
    Surgical and medical procedures
    Hematoma
    Additional description: Minor hematoma at site for blood sampling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Lightheadness and nausea after administration
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Skin irritation from abdominal belt for transit time evaluation
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Mild pain in right wrist during study period
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29291613
    http://www.ncbi.nlm.nih.gov/pubmed/26811503
    http://www.ncbi.nlm.nih.gov/pubmed/28986667
    http://www.ncbi.nlm.nih.gov/pubmed/26795566
    http://www.ncbi.nlm.nih.gov/pubmed/26610166
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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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