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    Clinical Trial Results:
    A 2-arm, randomised, single - (Investigator) blind, controlled, parallel design study in common cold sufferers experiencing nasal congestion to assess the speed of action of Vicks® VapoRub® (VVR)

    Summary
    EudraCT number
    		 2013-005006-66
    Trial protocol
    		 GB  
    Global end of trial date
    11 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2022
    First version publication date
    09 Jun 2022
    Other versions
    Summary report(s)
    		 Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    2013118
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Procter & Gamble Company
    Sponsor organisation address
    Mason Business Center, 8700 Mason-Montgomery Road, , Mason, United States, 45040-9462
    Public contact
    Sue Aspley, Procter&Gamble Tech Centres, aspley.s@pg.com
    Scientific contact
    Sue Aspley, Procter&Gamble Tech Centres, aspley.s@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
    17 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to investigate the speed of action of Vicks Vaporub (VVR) and to provide data to design a pivotal study.
    Protection of trial subjects
    Common cold patients were exposed to a single dose which minimized risk for any potential adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jan 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: 50
    Worldwide total number of subjects
    50
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects completed the study with no drop outs.

    Pre-assignment period milestones
    Number of subjects started
    		 50
    Number of subjects completed
    		 50

    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
    This was a single - (investigator) blind study, with limited access to the randomization code. 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.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Petrolatum
    Arm description
    		 -
    Arm type
    		 Petrolatum

    Investigational medicinal product name
    Vicks Vaporub
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    7.5g Topical application

    Arm title
    		 Vicks Vaporub
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vicks Vaporub
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    7.5g Topical application

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a single - (investigator) blind study, with limited access to the randomization code. 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.
    Number of subjects in period 1
    		Petrolatum Vicks Vaporub
    Started
    25
    25
    Completed
    25
    25

    Baseline characteristics

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    End points

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

    Reporting group title
    Vicks Vaporub
    Reporting group description
    		 -

    Primary: Primary

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    End point title
    		 Primary
    End point description
    Primary endpoint: time to first experiencing sensation of nasal cooling.
    End point type
    Primary
    End point timeframe
    Seconds
    End point values
    		 Petrolatum Vicks Vaporub
    Number of subjects analysed
    25
    25
    Units: First Sensation of nasal cooling
        number (not applicable)
    25
    25
    Statistical analysis title
    		 Kaplan-Meier LogRank Analysis
    Comparison groups
    Petrolatum v Vicks Vaporub
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Median
    Confidence interval

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    Secondary endpoint: time to first experiencing sensation of nasal decongestion.
    End point type
    Secondary
    End point timeframe
    Seconds
    End point values
    		 Petrolatum Vicks Vaporub
    Number of subjects analysed
    25
    25
    Units: sensation of nasal decongestion
        number (not applicable)
    25
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This was a single day study. Subjects could report adverse events directly after treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Petrolatum
    Reporting group description
    		 -

    Reporting group title
    Vicks Vaporub
    Reporting group description
    		 -

    Serious adverse events
    		 Petrolatum Vicks Vaporub
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (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
    		 Petrolatum Vicks Vaporub
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No Adverse Events were reported during this single day trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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