Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Placebo-Controlled, Double-Blind, Randomized, Parallel Group Pilot Study to Evaluate the Efficacy of Dextromethorphan Hydrobromide on Acute Cough in a Pediatric Population

    Summary
    EudraCT number
    		 2020-003216-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2020
    First version publication date
    30 Sep 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A6531002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02651116
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias Study Number: CHPA DXM
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this pilot study was to evaluate the endpoints and analyses that might be most appropriate to evaluate the efficacy of dextromethorphan hydrobromide (DXM HBr) 15 milligram (mg) per 10 millilitre (mL) versus placebo in children aged 6 to 11 years in a future study.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2016
    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
    United States: 131
    Worldwide total number of subjects
    131
    EEA total number of subjects
    0
    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)
    131
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was conducted in the United States from 25 February 2016 to 19 March 2020.

    Pre-assignment
    Screening details
    		 142 subjects were enrolled in a 2 hour run-in period, where they received 10 mL of non-medicinal liquid oral confection for once, and fitted with cough counting device VitaloJAKTM. Subjects who completed run-in period and qualified, were randomised to either dextromethorphan hydrobromide or placebo in a 4-day treatment period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dextromethorphan Hydrobromide
    Arm description
    		 Subjects were randomised to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of DXM HBr syrup in morning. Subjects were followed up for 14 days after last dose of study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan Hydrobromide
    Investigational medicinal product code
    Other name
    PF-02450388
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    On Day 1, subjects received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of DXM HBr syrup in morning.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomised to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of placebo syrup in morning. Subjects were followed up for 14 days after last dose of study medication.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    On Day 1, subjects received a single 10 mL oral dose of placebo syrup matched to DXM HBr each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of placebo syrup in morning.

    Number of subjects in period 1
    		Dextromethorphan Hydrobromide Placebo
    Started
    68
    63
    Treated
    68
    63
    Completed
    67
    62
    Not completed
    1
    1
         Adverse Event
    -
    1
         No Longer Willing To Participate In Study
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Dextromethorphan Hydrobromide
    Reporting group description
    		 Subjects were randomised to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of DXM HBr syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of placebo syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Reporting group values
    		 Dextromethorphan Hydrobromide Placebo Total
    Number of subjects
    		 68 63 131
    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)
    		 68 63 131
        Adolescents (12-17 years)
    		 0 0 0
        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)
    		 8.3 ± 1.57 8.0 ± 1.73 -
    Gender Categorical
    Units: Subjects
        Female
    		 35 32 67
        Male
    		 33 31 64
    Race
    Units: Subjects
        White
    		 40 39 79
        Black
    		 24 22 46
        Asian
    		 0 0 0
        Other
    		 4 2 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 7 11
        Not Hispanic or Latino
    		 64 56 120

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dextromethorphan Hydrobromide
    Reporting group description
    		 Subjects were randomised to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of DXM HBr syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of placebo syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Primary: Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1

    		 Close Top of page
    End point title
    		 Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1
    End point description
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated cough counts. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.
    End point type
    Primary
    End point timeframe
    Within 24 hours post-first dose on Day 1
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Cough counts
        arithmetic mean (standard deviation)
    457.1 ± 367.21
    676.8 ± 814.33
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Estimated rate ratio, and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter. Rate ratio refers to, ratio of rate of cough counts per 24 hours for DXM HBr to placebo.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0449 [1]
    Method
    		 Negative Binomial Regression
    Parameter type
    		 Ratio of rates
    Point estimate
    0.7899
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6273
         upper limit
    		 0.9947
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0929
    Notes
    [1] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Secondary: Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1

    		 Close Top of page
    End point title
    		 Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1
    End point description
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated cough counts. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Between dose 1 to dose 2 on Day 1
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    66
    61
    Units: Cough counts
        arithmetic mean (standard deviation)
    32.73 ± 30.597
    47.03 ± 57.729
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Estimated rate ratio, and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter. Rate ratio refers to, ratio of rate of cough counts per specified duration (used in evaluation of this endpoint) for DXM HBr to placebo.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0552 [2]
    Method
    		 Negative Binomial Regression
    Parameter type
    		 Ratio of rates
    Point estimate
    0.8048
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6446
         upper limit
    		 1.0049
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0912
    Notes
    [2] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Secondary: Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2

    		 Close Top of page
    End point title
    		 Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2
    End point description
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated cough counts. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Between dose 2 on Day 1 to dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2)
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    65
    61
    Units: Cough counts
        arithmetic mean (standard deviation)
    9.70 ± 8.877
    11.44 ± 13.193
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Estimated rate ratio, and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter. Rate ratio refers to, ratio of rate of cough counts per specified duration (used in evaluation of this endpoint) for DXM HBr to placebo.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.7684 [3]
    Method
    		 Negative Binomial Regression
    Parameter type
    		 Ratio of rates
    Point estimate
    0.9551
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7032
         upper limit
    		 1.2971
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1491
    Notes
    [3] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Secondary: Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2

    		 Close Top of page
    End point title
    		 Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2
    End point description
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated cough counts. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Between dose 3 to dose 4 on Day 2 (between first and second dose of Day 2)
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    65
    60
    Units: Cough counts
        arithmetic mean (standard deviation)
    19.32 ± 16.752
    33.62 ± 47.709
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Estimated rate ratio, and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter. Rate ratio refers to, ratio of rate of cough counts per specified duration (used in evaluation of this endpoint) for DXM HBr to placebo.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.022 [4]
    Method
    		 Negative Binomial Regression
    Parameter type
    		 Ratio of rates
    Point estimate
    0.7014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5178
         upper limit
    		 0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1086
    Notes
    [4] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Secondary: Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2

    		 Close Top of page
    End point title
    		 Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2
    End point description
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated cough counts. In this endpoint, as planned combined data is reported for first dosing interval (dose 1 to dose 2) on Day 1 and first dosing interval (dose 3 to dose 4) on Day 2. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Between dose 1 to dose 2 on Day 1 (between first and second dose of Day 1) and between dose 3 to dose 4 on Day 2 (between first and second dose of Day 2)
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    66
    61
    Units: Cough counts
        arithmetic mean (standard deviation)
    26.13 ± 21.498
    40.39 ± 49.896
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Estimated rate ratio, and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter. Rate ratio refers to, ratio of rate of cough counts per specified duration (used in evaluation of this endpoint) for DXM HBr to placebo.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0098 [5]
    Method
    		 Negative Binomial Regression
    Parameter type
    		 Ratio of rates
    Point estimate
    0.7454
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5964
         upper limit
    		 0.9316
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0848
    Notes
    [5] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Secondary: Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1

    		 Close Top of page
    End point title
    		 Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1
    End point description
    Time (in seconds) accumulated over a 24-hour period when cough events occurred was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the subject’s clothing at the neck or upper chest level, and a chest wall sensor attached to the subject’s chest at the top of the sternum. Data were captured on a data card and the vitalograph analyst evaluated total cough time accumulated. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.
    End point type
    Secondary
    End point timeframe
    Within 24 hours post-first dose on Day 1
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Seconds
        arithmetic mean (standard deviation)
    350.5 ± 268.95
    502.7 ± 566.57
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0977 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.221
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4831
         upper limit
    		 0.0411
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1324
    Notes
    [6] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Morning Cough Frequency at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Morning Cough Frequency at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond to “from when you woke up this morning until now, how much have you been coughing”, on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in morning time. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (morning screening visit on Day 1), Within 30 minutes of waking and before morning dose on Days 2, 3, and 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    3.4 ± 0.65
    3.3 ± 0.63
        Change at Day 2 (n= 66, 61)
    -1.2 ± 1.30
    -0.7 ± 1.15
        Change at Day 3 (n= 66, 60)
    -1.5 ± 1.15
    -1.1 ± 1.38
        Change at Day 4 (n= 66, 60)
    -2.0 ± 1.20
    -1.8 ± 1.40
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by subject, and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0191 [7]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.2881
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5287
         upper limit
    		 -0.0475
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1224
    Notes
    [7] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Morning Cough Severity at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Morning Cough Severity at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond to “how bad is your cough this morning”, on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in morning time. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (morning screening visit on Day 1), Within 30 minutes of waking and before morning dose on Days 2, 3, and 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    3.1 ± 0.54
    3.1 ± 0.60
        Change at Day 2 (n= 66, 61)
    -1.1 ± 0.89
    -0.6 ± 1.19
        Change at Day 3 (n= 66, 60)
    -1.4 ± 0.96
    -1.3 ± 1.22
        Change at Day 4 (n= 66, 60)
    -1.9 ± 1.10
    -1.8 ± 1.15
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by subject, and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0049 [8]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.3128
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5299
         upper limit
    		 -0.0956
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1104
    Notes
    [8] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Impact of Cough on Sleep at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Impact of Cough on Sleep at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond to “last night in bed, how much did your cough keep you awake”, on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated worse impact of cough on sleep. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (morning screening visit on Day 1), Within 30 minutes of waking and before morning dose on Days 2, 3, and 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    2.8 ± 1.15
    3.0 ± 1.19
        Change at Day 2 (n= 66, 61)
    -0.8 ± 1.56
    -0.7 ± 1.45
        Change at Day 3 (n= 66, 60)
    -1.3 ± 1.59
    -1.4 ± 1.67
        Change at Day 4 (n= 66, 60)
    -1.8 ± 1.57
    -1.9 ± 1.74
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by subject, and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.2679 [9]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.1483
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4112
         upper limit
    		 0.1146
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1337
    Notes
    [9] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Afternoon Cough Frequency at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Afternoon Cough Frequency at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond to “how much have you been coughing this afternoon” on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in afternoon time. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (afternoon visit on Day 1 before first dose), Before the afternoon dose on Days 2, and 3, Afternoon of Day 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    3.2 ± 0.80
    3.4 ± 0.73
        Change at Day 2 (n= 66, 61)
    -0.7 ± 1.25
    -0.6 ± 1.06
        Change at Day 3 (n= 66, 60)
    -1.5 ± 1.30
    -1.4 ± 1.27
        Change at Day 4 (n= 63, 58)
    -1.9 ± 1.22
    -1.8 ± 1.41
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by subject, and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0242 [10]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.2812
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5255
         upper limit
    		 -0.0369
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1242
    Notes
    [10] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Afternoon Cough Severity at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Afternoon Cough Severity at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond to “how bad is your cough this afternoon” on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in afternoon time. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (afternoon visit on Day 1 before first dose), Before the afternoon dose on Days 2, and 3, Anytime in afternoon of Day 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    2.8 ± 0.83
    3.1 ± 0.84
        Change at Day 2 (n= 66, 61)
    -0.7 ± 1.16
    -0.6 ± 0.98
        Change at Day 3 (n= 66, 60)
    -1.4 ± 1.15
    -1.4 ± 1.24
        Change at Day 4(n= 63, 58)
    -1.7 ± 1.08
    -1.6 ± 1.45
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by subject, and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0063 [11]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.3014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.517
         upper limit
    		 -0.0858
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1096
    Notes
    [11] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Change From Baseline in Child Global Question at Day 2, 3, and 4

    		 Close Top of page
    End point title
    		 Change From Baseline in Child Global Question at Day 2, 3, and 4
    End point description
    Subjects on specified time points were asked to respond on “how bad is your cold today”, on a 5-point scale; 0= no cold, 1= a tiny bit bad, 2= a little bad, 3= bad, and 4= very bad. Higher scores indicated worse cold. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'n' signifies number of subjects evaluable for specified time points.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (afternoon visit on Day 1 before first dose), Before the afternoon dose on Day 2, and 3, Anytime in afternoon of Day 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    67
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 67, 61)
    3.2 ± 0.42
    3.3 ± 0.46
        Change at Day 2 (n= 66, 61)
    -1.1 ± 1.02
    -0.9 ± 1.01
        Change at Day 3 (n= 66, 60)
    -1.6 ± 0.93
    -1.6 ± 1.13
        Change at Day 4 (n= 63, 58)
    -2.1 ± 0.87
    -1.7 ± 1.26
    Statistical analysis title
    		 Dextromethorphan Hydrobromide vs Placebo
    Statistical analysis description
    ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by subject and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0247 [12]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.2535
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4745
         upper limit
    		 -0.0325
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1124
    Notes
    [12] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Other pre-specified: Pediatric Global Assessment of Satisfaction With Study Medication: By Subject, and Caregiver

    		 Close Top of page
    End point title
    		 Pediatric Global Assessment of Satisfaction With Study Medication: By Subject, and Caregiver
    End point description
    Subjects at the end of the study were asked to respond to “How would you rate the study medication for taking away your cough?” on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication. Within 20 minutes after subjects completed the assessment parents/legally acceptable representative were asked to respond to “How would you rate the study medication for taking away your child’s cough?” on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication. Full analysis set included all subjects who were randomised, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    For subjects: at the end of the study on Day 4; For parents/legally acceptable representatives: within 20 minutes after subject completed assessment at the end of the study on Day 4
    End point values
    		 Dextromethorphan Hydrobromide Placebo
    Number of subjects analysed
    66
    61
    Units: Units on a scale
    arithmetic mean (standard deviation)
        By Subject:
    1.7 ± 1.20
    1.6 ± 1.26
        By Caregiver:
    1.8 ± 1.07
    1.9 ± 1.16
    Statistical analysis title
    		 Dextromethorphan HBr vs Placebo (Subject)
    Statistical analysis description
    ANOVA model with treatment, study site (pooled), and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.5652 [13]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    0.1266
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3081
         upper limit
    		 0.5614
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2196
    Notes
    [13] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.
    Statistical analysis title
    		 Dextromethorphan HBr vs Placebo (Caregiver)
    Statistical analysis description
    ANOVA model with treatment, study site (pooled), and age group included in the model.
    Comparison groups
    Dextromethorphan Hydrobromide v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.4914 [14]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.1368
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5292
         upper limit
    		 0.2556
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1982
    Notes
    [14] - P-Value <=0.05 level was considered significantly better and P-Value lying between 0.05<p<=0.1 level was considered marginally significantly better.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 14 days after last dose of study medication (up to 18 days)
    Adverse event reporting additional description
    Same event may appear as Adverse Event (AE) and Serious Adverse Events (SAE), what is presented are distinct events. Event may be categorised as serious in 1 subject and as non-serious in another subject or 1 subject may have experienced both serious and non-serious event during study. Evaluated on all subjects who received the study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomised to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of placebo syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Reporting group title
    Dextromethorphan Hydrobromide
    Reporting group description
    		 Subjects were randomised to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, subjects received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, subjects received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, subjects received a single 10 mL oral dose of DXM HBr syrup in morning. Subjects were followed up for 14 days after last dose of study medication.

    Serious adverse events
    		 Placebo Dextromethorphan Hydrobromide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (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: 0%
    Non-serious adverse events
    		 Placebo Dextromethorphan Hydrobromide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 63 (25.40%)
    13 / 68 (19.12%)
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 68 (1.47%)
         occurrences all number
    3
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tympanic membrane hyperaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Lip dry
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
         occurrences all number
    1
    1
    Nasal congestion
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nasal dryness
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nasal oedema
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nasal turbinate abnormality
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 68 (4.41%)
         occurrences all number
    1
    3
    Pharyngeal erythema
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
         occurrences all number
    1
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 68 (2.94%)
         occurrences all number
    3
    2
    Rhonchi
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dennie-Morgan fold
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Otitis media acute
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 06:55:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA