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    Clinical Trial Results:
    Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulation (apricot-flavored oral powder in sachet to be diluted).

    Summary
    EudraCT number
    		 2017-000278-13
    Trial protocol
    		 FR  
    Global end of trial date
    07 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P16-07/BP0.52
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIOPROJET Pharma
    Sponsor organisation address
    9 rue Rameau, Paris, France, 75002
    Public contact
    Bioprojet clinical departement, BIOPROJET PHARMA, 0033 (0)1 47 03 66 33, contact@bioprojet.com
    Scientific contact
    Bioprojet clinical departement, BIOPROJET PHARMA, 0033 (0)1 47 03 66 33, contact@bioprojet.com
    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
    30 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the non-inferiority of the palatability of a new paediatric formulation of Racecadotril strawberry-flavored administered as oral suspension via a graduated oral syringe compared to the current formulation (apricot-flavored oral powder pack) in healthy children 7-12 years of age.
    Protection of trial subjects
    The study was conducted in accordance with ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practices). Using the “swish and spit” methodology, the study drug is not swallowed following administration: the subject keeps it in the mouth for approximately 5 seconds and spits it out. This type of study minimizes the risk of adverse effect.
    Background therapy
    		 N/A
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2017
    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
    France: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    38
    Adolescents (12-17 years)
    2
    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
    		 -

    Pre-assignment
    Screening details
    		 Screening session could take place either before or on the day of taste testing. Each pair of subjects (child + his (her) parent) was assigned to the treatments in a random order. The same inclusion number was attributed to the child and his (her) parent.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Test Product
    Arm description
    		 This arm included 40 couples (one couple is composed of 1 children + 1 parent). Each formulation was to be evaluated twice according to a randomized cross-over design with 4 sequences: Control Product – Test Product – Control Product – Test Product Control Product – Test Product – Test Product – Control Product Test Product – Control Product – Test Product – Control Product Test Product – Control Product – Control Product – Test Product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tiorfan® 4 mg/mL, strawberry-flavored oral suspension (Test)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    The same dose of racecadotril, i.e. 5 mL corresponding to approximately 20 mg, was administered to all subjects (children and parents) whatever their weight, and according to the method “swish and spit”. The administration of 5 mL of each formulation was standardized as: - Tiorfan® 4 mg/mL, oral suspension administered directly into the mouth via an oral syringe graduated in kg (from 4-13 kg). - Tiorfan® 30 mg, oral powder packed in sachet, was diluted in 8 mL of water (in order to respect the same concentration as the suspension) and 5 mL transferred in a teaspoon for oral intake. Each formulation was administered twice resulting in 4 administrations, each separated by a free interval of 15 minutes.

    Arm title
    		 Control Product
    Arm description
    		 This arm included 40 couples (one couple is composed of 1 children + 1 parent) Each formulation was to be evaluated twice according to a randomized cross-over design with 4 sequences: Control Product – Test Product – Control Product – Test Product Control Product – Test Product – Test Product – Control Product Test Product – Control Product – Test Product – Control Product Test Product – Control Product – Control Product – Test Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tiorfan® 30 mg, apricot-flavored oral powder in sachet (Control)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    The same dose of racecadotril, i.e. 5 mL corresponding to approximately 20 mg, was administered to all subjects (children and parents) whatever their weight, and according to the method “swish and spit”. The administration of 5 mL of each formulation was standardized as: - Tiorfan® 4 mg/mL, oral suspension administered directly into the mouth via an oral syringe graduated in kg (from 4-13 kg). - Tiorfan® 30 mg, oral powder packed in sachet, was diluted in 8 mL of water (in order to respect the same concentration as the suspension) and 5 mL transferred in a teaspoon for oral intake. Each formulation was administered twice resulting in 4 administrations, each separated by a free interval of 15 minutes.

    Number of subjects in period 1
    		Test Product Control Product
    Started
    40
    40
    Completed
    40
    40

    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
    		 40 40
    Age categorical
    Subjects are composed of children and adults. Subjects are paired as a couple (1 children + 1 parent). The primary objective does not include the adult population.
    Units: Subjects
        Children (2-11 years)
    		 38 38
        Adolescents (12-17 years)
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.3 ± 1.4 -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    Test Product
    Reporting group description
    		 This arm included 40 couples (one couple is composed of 1 children + 1 parent). Each formulation was to be evaluated twice according to a randomized cross-over design with 4 sequences: Control Product – Test Product – Control Product – Test Product Control Product – Test Product – Test Product – Control Product Test Product – Control Product – Test Product – Control Product Test Product – Control Product – Control Product – Test Product

    Reporting group title
    Control Product
    Reporting group description
    		 This arm included 40 couples (one couple is composed of 1 children + 1 parent) Each formulation was to be evaluated twice according to a randomized cross-over design with 4 sequences: Control Product – Test Product – Control Product – Test Product Control Product – Test Product – Test Product – Control Product Test Product – Control Product – Test Product – Control Product Test Product – Control Product – Control Product – Test Product

    Primary: 7-point hedonic facial scale

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    End point title
    		 7-point hedonic facial scale
    End point description
    This is a self-assessment scale representing 7 facial emoticon symbols varying from “super bad” to “super good”. Just after each drug administration, the child was asked to choose the emoticon that represented best his/her sensation just after the spit. This endpoint was only assessed in the Evaluable population (N=40).
    End point type
    Primary
    End point timeframe
    Evaluations were performed just after the spit for children and 2 times for adults, just after the spit and 2 minutes later. The taste assessments for the child and his (her) parent were done simultaneously. Each subject performed 4 assessments.
    End point values
    		 Test Product Control Product
    Number of subjects analysed
    40 [1]
    40 [2]
    Units: score
        least squares mean (standard error)
    6 ± 0.2
    4.5 ± 0.2
    Notes
    [1] - Subjects analyzed are 40 children.
    [2] - Subjects analyzed are 40 children.
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    The primary analysis had to test the non-inferiority of the Test product (T), compared to the Control Product (C) using a 95% confidence interval. The difference (LS mean) Control - Test (C - T) was equal to - 1.5 (± 0.2). As the non-inferiority criterion was predefined as a difference of 2 points between product groups, the statistical analysis showed the non-inferiority of the Control Product compared to the Test product, with a highly statistical significance (p<0.0001).
    Comparison groups
    Test Product v Control Product
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The collection period for AEs and SAEs started after signature of the Informed Consent Form and ended after procedures for the last study visit have been completed or after the end of the study if thought to be related to study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Control Product
    Reporting group description
    		 -

    Reporting group title
    Test Product
    Reporting group description
    		 -

    Serious adverse events
    		 Control Product Test Product
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Product Test Product
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no reports of Adverse Events and Serious Adverse Events.

    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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