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    Clinical Trial Results:
    A 2-arm, randomised, single - (investigator) blind, controlled, parallel design study in common cold sufferers experiencing cough and nasal congestion to assess the effects of Vicks® VapoRub® (VVR) on elements of sleep quality

    Summary
    EudraCT number
    		 2013-004524-11
    Trial protocol
    		 GB  
    Global end of trial date
    15 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2016
    First version publication date
    20 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Procter and Gamble
    Sponsor organisation address
    Rusham Park, Egham, United Kingdom, TW20 9NW
    Public contact
    Dr David Hull, Procter and Gamble, +44 1784474408, hull.jd.2@pg.com
    Scientific contact
    Dr David Hull, Procter and Gamble, +44 1784474408, hull.jd.2@pg.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
    24 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy Objective: The objective of the study was to investigate the effects of VVR versus petrolatum on subjective and objective sleep measurements in subjects with the common cold.
    Protection of trial subjects
    Participants were supervised by appropriately trained and delegated staff throughout their study visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2014
    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
    United Kingdom: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 100 participants were recruited in the United Kingdom between 05-Nov-2014 and 11-May-2015.

    Pre-assignment
    Screening details
    		 Healthy male and female participants, aged 18-65 yrs, suffering from a self-diagnosed common cold of no more than 36 hours’ duration. 141 potential participants were screened. There were 20 screen failures and 21 people were pre-screened but never returned with a cold.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    Only the Clinical Supplies Department of P&G (Bracknell, UK) and qualified study centre designee(s) responsible for handling the study medications at the site had access to the study medication sequence and codes. The study medication codes were controlled by the Clinical Supplies Department of P&G (Bracknell, UK). The designee(s) were not involved in any other aspects related to the conduct of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Petrolatum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Sonneborn Refined Products BV, Parsippany, NJ, USA. Test product was applied at home by the subjects once on each of 2 nights immediately before retiring to bed (7.5 g each night sequentially over the regions of the chest, throat, and back). Additional instructions were provided to ensure that all 7.5 g of product was applied.

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vicks VapoRub
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Vicks® VapoRub® includes a combination of levomenthol (2.75% w/w), eucalyptus oil (1.5% w/w), turpentine oil (5% w/w) and camphor (5% w/w) as active ingredients, and thymol, cedarwood oil, and white soft paraffin as excipients. Test product was applied at home by the subjects once on each of 2 nights immediately before retiring to bed (7.5 g each night sequentially over the regions of the chest, throat, and back). Additional instructions were provided to ensure that all 7.5 g of product was applied.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the nature of the study products it was not possible for participants to be blinded, however, study investigators interacting with the participants were blinded.
    Number of subjects in period 1
    		Placebo Active
    Started
    50
    50
    Completed
    50
    49
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Active Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 23.7 (18 to 52) 23.1 (18 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 29 32 61
        Male
    		 21 18 39

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Primary: Subjective Sleep Quality (Visual Analogue Scale)

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    End point title
    		 Subjective Sleep Quality (Visual Analogue Scale)
    End point description
    Change from baseline least squares mean (standard error)
    End point type
    Primary
    End point timeframe
    Baseline, Test Period: Day 1 and day 2
    End point values
    		 Placebo Active
    Number of subjects analysed
    47
    46
    Units: mm
        least squares mean (standard error)
    -13.7 ± 2.65
    -21.6 ± 2.68
    Statistical analysis title
    		 Primary Endpoint
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All treatment-emergent AEs (serious and non-serious) were captured.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Vicks Vapour Rub

    Reporting group title
    Comparator
    Reporting group description
    		 Petrolatum

    Serious adverse events
    		 Active Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (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
    		 Active Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 50 (10.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    Paraesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site warmth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Ear infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2015
    The amendment allowed a subject who failed eligibility at Day 0 to be re-screened if 1) the subject experienced a new common cold and 2) the reason the subject did not initially qualify was due to a transient, resolved ineligibility (eg, changes in the intensity or duration of the cold or severity of acute sleep issues or prohibited medication changes, etc.

    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.

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