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    Clinical Trial Results:
    Palliation of dyspnea with morphine in patients with interstitial lung disease

    Summary
    EudraCT number
    		 2015-002533-22
    Trial protocol
    		 DK  
    Global end of trial date
    06 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2020
    First version publication date
    20 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EB-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02622022
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus C, Denmark,
    Public contact
    Dept of respiratory diseases, Aarhus University Hospital, karbends@rm.dk
    Scientific contact
    Dept of respiratory diseases, Aarhus University Hospital, karbends@rm.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
    01 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if morphine hydrochloride administered for 7 days is safe and attenuates dyspnea in patients with interstitial lung disease and dyspnea
    Protection of trial subjects
    All patients were provided with a prescription of macrogol to counteract consitpation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Denmark: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    5
    From 65 to 84 years
    30
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Fibrotic intersititial lung disease

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Morphine
    Arm description
    		 Morphine oral drops 5 mg 4 times daily + 5 mg max. 4 times daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    5 drops four times daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    5 drops four times daily

    Number of subjects in period 1
    		Morphine Placebo
    Started
    18
    18
    Completed
    17
    18
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Morphine
    Reporting group description
    		 Morphine oral drops 5 mg 4 times daily + 5 mg max. 4 times daily

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Morphine Placebo Total
    Number of subjects
    		 18 18 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2 3 5
        From 65-84 years
    		 16 14 30
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 72.5 (70 to 80) 75 (73 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 6
        Male
    		 15 15 30

    End points

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    End points reporting groups
    Reporting group title
    Morphine
    Reporting group description
    		 Morphine oral drops 5 mg 4 times daily + 5 mg max. 4 times daily

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: change in VAS dyspnea score during last week

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    End point title
    		 change in VAS dyspnea score during last week
    End point description
    End point type
    Primary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: cm
        arithmetic mean (standard error)
    -1.1 ( 0.33 )
    -0.35 ( 0.46 )
    Statistical analysis title
    		 t-test
    Comparison groups
    Placebo v Morphine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in VAS cough during last week

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    End point title
    		 Change in VAS cough during last week
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: cm
        arithmetic mean (standard error)
    -0.15 ( 0.24 )
    -0.07 ( 0.34 )
    No statistical analyses for this end point

    Secondary: Change in 6 minute walk test

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    End point title
    		 Change in 6 minute walk test
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: m
        arithmetic mean (standard error)
    10 ( 9 )
    5 ( 6 )
    No statistical analyses for this end point

    Secondary: Change in Respiratory rate

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    End point title
    		 Change in Respiratory rate
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: / minute
        arithmetic mean (standard error)
    -0.8 ( 1.1 )
    2.6 ( 1.1 )
    No statistical analyses for this end point

    Secondary: PaO2

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    End point title
    		 PaO2
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: kPA
        median (inter-quartile range (Q1-Q3))
    -0.6 (-1.3 to 0.9)
    -0.2 (-0.8 to 1)
    No statistical analyses for this end point

    Secondary: Change in PaCO2

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    End point title
    		 Change in PaCO2
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: Kpa
        arithmetic mean (standard error)
    0.2 ( 0.1 )
    0.02 ( 0.1 )
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure

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    End point title
    		 Change in systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: mmHg
        arithmetic mean (standard error)
    1.2 ( 4.9 )
    0.1 ( 2.9 )
    No statistical analyses for this end point

    Secondary: Change in respiratory rate

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    End point title
    		 Change in respiratory rate
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: pr minute
        arithmetic mean (standard error)
    -0.8 ( 1.1 )
    2.6 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Change in Heart rate

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    End point title
    		 Change in Heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: pr minute
        arithmetic mean (standard error)
    -2.1 ( 2.5 )
    -5.2 ( 2.7 )
    No statistical analyses for this end point

    Secondary: Change in KBILD score

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    End point title
    		 Change in KBILD score
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: points
        arithmetic mean (standard error)
    2.9 ( 1.6 )
    1.6 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Change in Leicester cough score

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    End point title
    		 Change in Leicester cough score
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: points
        arithmetic mean (standard error)
    1.2 ( 0.4 )
    0.2 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change in GAD score

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    End point title
    		 Change in GAD score
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Morphine Placebo
    Number of subjects analysed
    17
    18
    Units: Points
        arithmetic mean (standard error)
    -0.4 ( 0.7 )
    -0.6 ( 0.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One week
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Morphine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Morphine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Morphine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 18 (83.33%)
    11 / 18 (61.11%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 18 (27.78%)
    5 / 18 (27.78%)
         occurrences all number
    5
    5
    Dizziness
         subjects affected / exposed
    12 / 18 (66.67%)
    8 / 18 (44.44%)
         occurrences all number
    12
    8
    Confusional arousal
         subjects affected / exposed
    7 / 18 (38.89%)
    2 / 18 (11.11%)
         occurrences all number
    7
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 18 (38.89%)
    2 / 18 (11.11%)
         occurrences all number
    7
    2
    Nausea
         subjects affected / exposed
    8 / 18 (44.44%)
    4 / 18 (22.22%)
         occurrences all number
    8
    4

    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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    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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