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    Clinical Trial Results:
    Intranasal Sufentanyl analgesia Versus Morphine IV in Emergency room.

    Summary
    EudraCT number
    		 2013-001665-16
    Trial protocol
    		 FR  
    Global end of trial date
    10 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2022
    First version publication date
    02 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    38RC13.558
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02095366
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Grenoble Alpes
    Sponsor organisation address
    Boulevard de la Chantourne, La tronche, France,
    Public contact
    Blancher, University Hospital Grenoble, 33 047676630246, arcpromoteur@chu-grenoble.fr
    Scientific contact
    Blancher, University Hospital Grenoble, 33 047676630246, arcpromoteur@chu-grenoble.fr
    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
    28 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    verify the non-inferiority of analgesia with Sufentanil administered by intranasal spray compared to the reference analgesic treatment (Morphine intravenously) in patients hospitalized in the emergency room, presenting pain of traumatic origin estimated ≥ 6 on the numeric self-assessment pain scale.
    Protection of trial subjects
    The study does not pose additional risks to participating subjects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2013
    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
    France: 157
    Worldwide total number of subjects
    157
    EEA total number of subjects
    157
    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)
    157
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult patients (18 to 75 years old) presenting with traumatic pain self-evaluated as >6/10 on a numerical pain rating scale (NRS) were recruited at triage in 6 hospital emergency departments

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intranasal sufentanil
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUFENTANIL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    initial dose of 0.30 μg/kg sufentanil (0.15 μg/kg in each nostril) was administered. Additional doses (0.15 μg/kg) were administered at 10 and 20 minutes in 1 of the nostrils if NRS remained >3/10

    Investigational medicinal product name
    PLACEBO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo

    Arm title
    		 MORPHINE IV
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MORPHINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Solution for infusion
    Dosage and administration details
    an initial dose of 0.1 mg/kg was administered, and additional doses of 0.05 mg/kg at 10 and 20 minutes if the NRS remained >3/10.

    Number of subjects in period 1
    		Intranasal sufentanil MORPHINE IV
    Started
    77
    80
    Completed
    76
    79
    Not completed
    1
    1
         Physician decision
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 157 157
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 157 157
    Gender categorical
    Units: Subjects
        Female
    		 74 74
        Male
    		 83 83

    End points

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    End points reporting groups
    Reporting group title
    Intranasal sufentanil
    Reporting group description
    		 -

    Reporting group title
    MORPHINE IV
    Reporting group description
    		 -

    Primary: non-inferiority of analgesia with Sufentanil administered by intranasal spray compared to the reference analgesic treatment

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    End point title
    		 non-inferiority of analgesia with Sufentanil administered by intranasal spray compared to the reference analgesic treatment
    End point description
    non-inferiority of analgesia with Sufentanil administered by intranasal spray compared to the reference analgesic treatment (Morphine intravenously) in patients hospitalized in the emergency room, presenting pain of traumatic origin estimated ≥ 6 on the scale of digital self-assessment of pain (EN).
    End point type
    Primary
    End point timeframe
    T 30 minutes
    End point values
    		 Intranasal sufentanil MORPHINE IV
    Number of subjects analysed
    67
    69
    Units: scale of digital self-assessment of pain
        number (not applicable)
    67
    69
    Statistical analysis title
    		 intention to treat analysis
    Statistical analysis description
    2 groups
    Comparison groups
    Intranasal sufentanil v MORPHINE IV
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [1]
    Method
    		 Schuirmann
    Parameter type
    		 Schuirmann
    Confidence interval
    Notes
    [1] - p < 0.001),

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    T - T10 - T20 - T30
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    morphine iv
    Reporting group description
    		 -

    Reporting group title
    sufentanil
    Reporting group description
    		 -

    Serious adverse events
    		 morphine iv sufentanil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 80 (3.75%)
    10 / 77 (12.99%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 77 (3.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoventilation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradypnea
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 morphine iv sufentanil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 77 (0.00%)
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 77 (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
    13 Apr 2014
    temporary stop of research
    23 Apr 2014
    ADDITION OF A SECONDARY OBJECTIVE: 30 "PRE-HOSPITAL" PATIENTS Restart of the research
    18 Nov 2014
    opening of a new investigation center, the Saint Jean de Maurienne hospital center and reducing the inclusion objective of two investigation centers, experiencing difficulties recruiting from 30 patients to 20 patients: Voiron hospital center and Hôpital Sud Grenoble
    22 Oct 2015
    Addition of a new centre: Services des Urgences du Center Hospitalier d’Albertville, and a new investigator. - Addition of 3 co-investigators at St Jean de Maurienne - Removal of the center of Voiron - Extension of the duration of the study until August 31, 2016.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Apr 2014
    under-dosage of Sufentanil vials in the kits
    02 Oct 2014

    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/31310600
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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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