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    Clinical Trial Results:
    Efficacy and safety of an alcohol-free formulation of 0.15% benzydamine spray in children with sore throat. Randomized, double blind, placebo-controlled study

    Summary
    EudraCT number
    		 2009-014401-13
    Trial protocol
    		 IT   AT   SK   RO   ES  
    Global end of trial date
    21 Oct 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Aug 2018
    First version publication date
    02 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Changes to summary attachments
    A summary of results is uploaded replacing the CSR
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    030(B)SC09047
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ACRAF SpA
    Sponsor organisation address
    Piazzale della stazione, s.n.c., S.Palomba- Pomezia (Rome), Italy, 00071
    Public contact
    Clinical Trial application Unit, ACRAF SpA, +39 0691045335, ctaunit@angelini.it
    Scientific contact
    Clinical Trial application Unit, ACRAF SpA, +39 0691045432, ctaunit@angelini.it
    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
    07 Mar 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the analgesic activity of 0.15% benzydamine spray in single administration compared to placebo.
    Protection of trial subjects
    The study was performed in accordance with the protocol (unless otherwise indicated), Good Clinical Practice (GCP) requirements, the Declaration of Helsinki (updated version), and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2010
    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
    Romania: 89
    Country: Number of subjects enrolled
    Slovakia: 10
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Austria: 40
    Country: Number of subjects enrolled
    Italy: 59
    Worldwide total number of subjects
    201
    EEA total number of subjects
    201
    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)
    194
    Adolescents (12-17 years)
    7
    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
    		 Participants were male and female outpatients 6-12 years old with objective findings that confirm the sore throat diagnosis with Tonsillo-Pharyngitis Scale > 6 points; onset of sore throat symptoms within 7 days; moderate-to-severe sore throat (Children’s Sore Throat Pain Thermometer > 120mm).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benzydamine
    Arm description
    		 Benzydamnine 0,15 % spray, a single application (4 nebulizations).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benzydamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A single application constituted of 4 nebulizations; each nebulization corresponds to 1.17 ml and contains about 0.25 mg of benzydamine.

    Arm title
    		 Placebo
    Arm description
    		 Placebo spray, a single application ( 4 nebulizations).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A single application, constituted of 4 nebulizations.

    Number of subjects in period 1
    		Benzydamine Placebo
    Started
    99
    102
    Completed
    99
    102

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benzydamine
    Reporting group description
    		 Benzydamnine 0,15 % spray, a single application (4 nebulizations).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo spray, a single application ( 4 nebulizations).

    Reporting group values
    		 Benzydamine Placebo Total
    Number of subjects
    		 99 102 201
    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)
    		 95 99 194
        Adolescents (12-17 years)
    		 4 3 7
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.8 ( 1.8 ) 8.7 ( 1.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 57 104
        Male
    		 52 45 97

    End points

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    End points reporting groups
    Reporting group title
    Benzydamine
    Reporting group description
    		 Benzydamnine 0,15 % spray, a single application (4 nebulizations).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo spray, a single application ( 4 nebulizations).

    Primary: SPID Child ITT population

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    End point title
    		 SPID Child ITT population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Thermometer scale by the child. CSTPT is a vertical 21 point (200 mm) VAS anchored on the bottom by the sentence “IT DOESN’T HURT AT ALL” and at the top “IT HURTS A LOT”, divided at 1 cm intervals from 0 to 20.
    End point type
    Primary
    End point timeframe
    Baseline and then after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: mm
        arithmetic mean (standard deviation)
    -3919.1 ( 2629.7 )
    -4127.7 ( 2495.6 )
    Statistical analysis title
    		 SPID child: Benzydamine- Placebo/ITT
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7041 [1]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Not significant

    Primary: SPID Child PP population

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    End point title
    		 SPID Child PP population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Thermometer scale by the child. CSTPT is a vertical 21 point (200 mm) VAS anchored on the bottom by the sentence “IT DOESN’T HURT AT ALL” and at the top “IT HURTS A LOT”, divided at 1 cm intervals from 0 to 20.
    End point type
    Primary
    End point timeframe
    Baseline and after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    81
    80
    Units: mm
        arithmetic mean (standard deviation)
    -3855.9 ( 2696.8 )
    -4276.5 ( 2567.2 )
    Statistical analysis title
    		 SPID child: Benzydamine-Placebo/PP
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7277 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - Not significant

    Secondary: SPID Parent ITT population

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    End point title
    		 SPID Parent ITT population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Intensity scale by the parent. This scale is a horizontal VAS presented as a line (100 mm in length) anchored by word descriptors at each end: on the left by thesentence “NO PAIN”, and on the right “VERY SEVERE PAIN”.
    End point type
    Secondary
    End point timeframe
    Baseline and then after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: mm
        arithmetic mean (standard deviation)
    -1830.7 ( 1202.5 )
    -1922.9 ( 1387.1 )
    Statistical analysis title
    		 SPID parent : Benzydamine- Placebo/ITT
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7041 [3]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Not significant

    Secondary: SPID Investigator ITT population

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    End point title
    		 SPID Investigator ITT population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Intensity scale by the investigator. This scale is a horizontal VAS presented as a line (100 mm in length) anchored by word descriptors at each end: on the left by the sentence “NO PAIN”, and on the right “VERY SEVERE PAIN”.
    End point type
    Secondary
    End point timeframe
    Baseline and then after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: mm
        arithmetic mean (standard deviation)
    -1902.5 ( 1012.1 )
    -1895.7 ( 1176.8 )
    Statistical analysis title
    		 SPID investigator: Benzydamine- Placebo/ITT
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7303 [4]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - Not significant

    Secondary: TOTPAR Child ITT population

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    End point title
    		 TOTPAR Child ITT population
    End point description
    Children’s Sore Throat Relief was estimated as the area under the pain relief versus time curve (TOTPAR). At all fixed times, the child was also asked to indicate pain intensity using the horizontal scale to rate the sore throat relief, consisting of 5 cartoon faces ranging from a tearful face for “NO RELIEF “ on the left to a smiling face for “COMPLETE RELIEF “ on the right.
    End point type
    Secondary
    End point timeframe
    After 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: score on a scale
        arithmetic mean (standard deviation)
    214.1 ( 65.1 )
    217.3 ( 65.6 )
    Statistical analysis title
    		 TOTPAR: Benzydamine-Placebo/ITT
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9082 [5]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - Not significant

    Secondary: SPID Parent PP population

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    End point title
    		 SPID Parent PP population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Intensity Scale by the parent. This scale is a horizontal VAS presented as a line (100 mm in length) anchored by word descriptors at each end: on the left by the sentence “NO PAIN”, and on the right “VERY SEVERE PAIN”.
    End point type
    Secondary
    End point timeframe
    Baseline and after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    81
    80
    Units: mm
        arithmetic mean (standard deviation)
    -1738.5 ( 1254.5 )
    -1984.6 ( 1460.5 )
    Statistical analysis title
    		 SPID parent : Benzydamine- Placebo/PP
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7708 [6]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [6] - Not significant

    Secondary: SPID Investigator PP population

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    End point title
    		 SPID Investigator PP population
    End point description
    Sum of Pain Intensity Difference Score (SPID) of the Children’s Sore Throat Pain Intensity scale by the investigator. This scale is a horizontal VAS presented as a line (100 mm in length) anchored by word descriptors at each end: on the left by the sentence “NO PAIN”, and on the right “VERY SEVERE PAIN”.
    End point type
    Secondary
    End point timeframe
    Baseline and after 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    81
    80
    Units: mm
        arithmetic mean (standard deviation)
    -1894.2 ( 1055.7 )
    -1963.8 ( 1248.2 )
    Statistical analysis title
    		 SPID investigator : Benzydamine- Placebo/PP
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5945 [7]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - Not significant

    Secondary: TOTPAR Child PP population

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    End point title
    		 TOTPAR Child PP population
    End point description
    Children’s Sore Throat Relief was estimated as the area under the pain relief versus time curve (TOTPAR). At all fixed times, the child was also asked to indicate pain intensity using the horizontal scale to rate the sore throat relief, consisting of 5 cartoon faces ranging from a tearful face for “NO RELIEF “ on the left to a smiling face for “COMPLETE RELIEF “ on the right.
    End point type
    Secondary
    End point timeframe
    After 15, 30, 45, 60 and 90 minutes from the study medications administrations.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    81
    79
    Units: score on a scale
        arithmetic mean (standard deviation)
    214.1 ( 69.5 )
    220.5 ( 68.5 )
    Statistical analysis title
    		 TOTPAR: Benzydamine-Placebo/PP
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8113 [8]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [8] - Not significant

    Secondary: Tolerability evaluation Investigator/ good 90 minutes

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    End point title
    		 Tolerability evaluation Investigator/ good 90 minutes
    End point description
    A global tolerability rating was expressed by the Investigator through a 5-point categorical scale (very good, good, fair, poor and very poor).
    End point type
    Secondary
    End point timeframe
    after 90 minutes and 4 days post-treatment
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    1
    0
    Statistical analysis title
    		 Tolerabiliy evaluation investigator
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3173 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - Not significant

    Secondary: Tolerability evaluation Investigator/very good 90 minutes

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    End point title
    		 Tolerability evaluation Investigator/very good 90 minutes
    End point description
    A global tolerability rating was expressed by the Investigator through a 5-point categorical scale (very good, good, fair, poor and very poor).
    End point type
    Secondary
    End point timeframe
    after 90 minutes and 4 days post-treatment
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    99
    100
    Statistical analysis title
    		 Tolerabiliy evaluation investigator
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3173 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - Not significant

    Secondary: Tolerability evaluation Investigator/ good Day 4

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    End point title
    		 Tolerability evaluation Investigator/ good Day 4
    End point description
    A global tolerability rating was expressed by the Investigator through a 5-point categorical scale (very good, good, fair, poor and very poor).
    End point type
    Secondary
    End point timeframe
    after 90 minutes and 4 days post-treatment
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    0
    1
    Statistical analysis title
    		 Tolerabiliy evaluation investigator
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3173 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [11] - Not significant

    Secondary: Tolerability evaluation Investigator/ very good Day 4

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    End point title
    		 Tolerability evaluation Investigator/ very good Day 4
    End point description
    A global tolerability rating was expressed by the Investigator through a 5-point categorical scale (very good, good, fair, poor and very poor).
    End point type
    Secondary
    End point timeframe
    after 90 minutes and 4 days post-treatment
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    100
    99
    Statistical analysis title
    		 Tolerabiliy evaluation investigator
    Comparison groups
    Benzydamine v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3173 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [12] - Not significant

    Secondary: Taste evaluation Child- Fresh

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    End point title
    		 Taste evaluation Child- Fresh
    End point description
    The Investigator asked the children the taste of the administered formulation, in terms of fresh (yes/no), sweet (yes/no), bitter (yes/no), and a global assessment in terms of good or bad. Only positive answers are reported.
    End point type
    Secondary
    End point timeframe
    After the first administration and before the first efficacy assessment.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    88.9
    88.2
    No statistical analyses for this end point

    Secondary: Taste evaluation Child- Sweet

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    End point title
    		 Taste evaluation Child- Sweet
    End point description
    The Investigator asked the children the taste of the administered formulation, in terms of fresh (yes/no), sweet (yes/no), bitter (yes/no), and a global assessment in terms of good or bad. Only positive answers are reported.
    End point type
    Secondary
    End point timeframe
    After the first administration and before the first efficacy assessment.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    67.7
    66.7
    No statistical analyses for this end point

    Secondary: Taste evaluation Child- Bitter

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    End point title
    		 Taste evaluation Child- Bitter
    End point description
    The Investigator asked the children the taste of the administered formulation, in terms of fresh (yes/no), sweet (yes/no), bitter (yes/no), and a global assessment in terms of good or bad. Only positive answers are reported.
    End point type
    Secondary
    End point timeframe
    After the first administration and before the first efficacy assessment.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    12.1
    14.7
    No statistical analyses for this end point

    Secondary: Taste evaluation Child- Global assessment- Good

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    End point title
    		 Taste evaluation Child- Global assessment- Good
    End point description
    The Investigator asked the children the taste of the administered formulation, in terms of global assessment in terms of good or bad.
    End point type
    Secondary
    End point timeframe
    After the first administration and before the first efficacy assessment.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    90.9
    93.1
    No statistical analyses for this end point

    Secondary: Taste evaluation Child- Global assessment- Bad

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    End point title
    		 Taste evaluation Child- Global assessment- Bad
    End point description
    The Investigator asked the children the taste of the administered formulation, in terms of global assessment in terms of good or bad.
    End point type
    Secondary
    End point timeframe
    After the first administration and before the first efficacy assessment.
    End point values
    		 Benzydamine Placebo
    Number of subjects analysed
    99
    102
    Units: percent
        number (not applicable)
    9.1
    6.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the final visit (day 4)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Benzydamine
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Benzydamine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 99 (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
    		 Placebo Benzydamine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 102 (12.75%)
    12 / 99 (12.12%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 102 (6.86%)
    7 / 99 (7.07%)
         occurrences all number
    7
    7

    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
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