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    Clinical Trial Results:
    Study of the intranasal fentanyl tolerance in procedural pain in the elderly, with or without background treatment.

    Summary
    EudraCT number
    		 2014-003156-31
    Trial protocol
    		 FR  
    Global end of trial date
    24 Oct 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    38RC14.245
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de GRENOBLE
    Sponsor organisation address
    CS 2017, Grenoble, France, 38043
    Public contact
    Pr GAVAZZI, CHU de GRENOBLE, MCoutard@chu-grenoble.fr
    Scientific contact
    Pr GAVAZZI, CHU de GRENOBLE, MCoutard@chu-grenoble.fr
    Sponsor organisation name
    CHU de GRENOBLE
    Sponsor organisation address
    CS 2017, Grenoble, France, 38043
    Public contact
    CHU de GRENOBLE, CHU de GRENOBLE, ARCpromoteur@chu-grenoble.fr
    Scientific contact
    CHU de GRENOBLE, CHU de GRENOBLE, 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
    06 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of transmucosal fentanyl (Pecfent®) in the procedural pain of the elderly patient.
    Protection of trial subjects
    An oversight committee independent of the proponent is foreseen as part of this study. This committee may propose to the sponsor and the coordinating investigator, the cessation of this research or a modification of the protocol if the safety of the subjects suitable for the study does not seem sufficient. The Committee will meet at half of the inclusions in the study and in the event of an unexpected serious adverse reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Dec 2014
    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: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    0
    From 65 to 84 years
    11
    85 years and over
    47

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study will be proposed to all patients with a EVA > 4 during nursing

    Period 1
    Period 1 title
    Evaluation without fentanyl
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    non applicable

    Arms
    Arm title
    		 baseline
    Arm description
    		 -
    Arm type
    		 no product

    Investigational medicinal product name
    PLACEBO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    no adminsitration of product

    Number of subjects in period 1
    		baseline
    Started
    58
    Completed
    58
    Period 2
    Period 2 title
    Evaluation with fentanyl
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fentanyl administration
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    fentanyl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Intranasal use
    Dosage and administration details
    starting with 100µg, with the possibility of increasing dosage over successive procedures according to pain assessments up to 400µg for opioid naïve patients and up to 800µg for others

    Number of subjects in period 2
    		Fentanyl administration
    Started
    58
    Completed
    58

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -
    Reporting group title
    Fentanyl administration
    Reporting group description
    		 -

    Subject analysis set title
    analyse finale
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All quantitative variables are described by their mean, median, minimum, maximum, first and third quartiles. Qualitative parameters are expressed as numbers and percentages

    Primary: Primary end point EVA

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    End point title
    		 Primary end point EVA
    End point description
    The effectiveness on pain will be evaluated with a 10 cm EVA that will be offered to the patient. The first six sessions of care, the patient will assess the pain he feels - 10 minutes before the start of the treatment, just before taking Pecfent® when it is administered. - during the treatment at 15 minutes compared to t0, after 5 minutes of treatment. - during the treatment, 30 minutes after t0, after 20 minutes of care. - A final evaluation will be made at 1 hour from the end of the care
    End point type
    Primary
    End point timeframe
    - 10 minutes before the start of the treatment, - during the treatment at 15 minutes compared to t0, after 5 minutes of treatment. - during the treatment, 30 minutes after t0, after 20 minutes of care. - A final evaluation will be made at 1 hour from
    End point values
    		 Fentanyl administration baseline
    Number of subjects analysed
    58
    58
    Units: cm
        number (not applicable)
    58
    58
    Statistical analysis title
    		 Shapiro-Wilks
    Comparison groups
    Fentanyl administration v baseline
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reporting was during all the study course at each adminsitration and visits
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Fentanyl Administration
    Reporting group description
    		 -

    Serious adverse events
    		 Fentanyl Administration
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 58 (6.90%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Cheyne-Stokes respiration
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Product issues
    Accidental overdose
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fentanyl Administration
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 58 (27.59%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    0
    Vomiting
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2016
    This request for a substantial amendment is intended to update the Pecfent® SPC and consequently the relevant paragraphs in the Protocol. In addition, the chapter on vigilance of this study has been updated
    28 Oct 2016
    This amendment aims to remove the distribution of the number of patients to be included (30 pressure ulcer treatments / 30 rehabilitation), in order to be able to increase the number of volunteers that can be included in the "mobilization" group without changing the total number of planned inclusions. This substantial amendment is also intended to update the Pecfent® SPC and consequently the relevant paragraphs in the Protocol.
    22 Feb 2017
    This amendment aims to add 2 co-investigators: Dr. Mitha and Dr. Zerhouni This substantial amendment also aims to update the Pecfent's® SPC and update the composition of the independent oversight committee.
    26 Jun 2017
    This amendment aims to extend the recruitment period of subjects by 6 months which brings the maximum date of last visit of the last patient to 09/12/2017.

    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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