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
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EudraCT number |
2013-005006-66 |
Trial protocol |
GB |
Global end of trial date |
11 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Jun 2022
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First version publication date |
09 Jun 2022
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Other versions |
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Summary report(s) |
Final Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2013118
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
The Procter & Gamble Company
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Sponsor organisation address |
Mason Business Center, 8700 Mason-Montgomery Road, , Mason, United States, 45040-9462
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Public contact |
Sue Aspley, Procter&Gamble Tech Centres, aspley.s@pg.com
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Scientific contact |
Sue Aspley, Procter&Gamble Tech Centres, aspley.s@pg.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Mar 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
Common cold patients were exposed to a single dose which minimized risk for any potential adverse events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
50
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
All subjects completed the study with no drop outs. | |||||||||
Pre-assignment period milestones
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Number of subjects started |
50 | |||||||||
Number of subjects completed |
50 | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Petrolatum | |||||||||
Arm description |
- | |||||||||
Arm type |
Petrolatum | |||||||||
Investigational medicinal product name |
Vicks Vaporub
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Topical use
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Dosage and administration details |
7.5g Topical application
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Arm title
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Vicks Vaporub | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Vicks Vaporub
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Topical use
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Dosage and administration details |
7.5g Topical application
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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. |
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End points reporting groups
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Reporting group title |
Petrolatum
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Reporting group description |
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Reporting group title |
Vicks Vaporub
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Reporting group description |
- |
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End point title |
Primary | ||||||||||||
End point description |
Primary endpoint: time to first experiencing sensation of nasal cooling.
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End point type |
Primary
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End point timeframe |
Seconds
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Statistical analysis title |
Kaplan-Meier LogRank Analysis | ||||||||||||
Comparison groups |
Petrolatum v Vicks Vaporub
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Number of subjects included in analysis |
50
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
Median | ||||||||||||
Confidence interval |
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End point title |
Secondary | ||||||||||||
End point description |
Secondary endpoint: time to first experiencing sensation of nasal decongestion.
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End point type |
Secondary
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End point timeframe |
Seconds
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
This was a single day study. Subjects could report adverse events directly after treatment.
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Petrolatum
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Vicks Vaporub
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Reporting group description |
- | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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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. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |