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   43851   clinical trials with a EudraCT protocol, of which   7283   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 Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants with Induced Viral Upper Respiratory Tract Infection

    Summary
    EudraCT number
    		 2017-000472-28
    Trial protocol
    		 GB  
    Global end of trial date
    19 Nov 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Feb 2020
    First version publication date
    27 Nov 2019
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-7264-013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03569033
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    19 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jul 2018
    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: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were in good general health and susceptible to human rhinovirus type 16 (HRV-16). Additional inclusion criteria applied.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gefapixant 45 mg BID
    Arm description
    		 Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    MK-7264
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 45 mg gefapixant tablet BID for 7 days

    Arm title
    		 Placebo BID
    Arm description
    		 Participants received a matching placebo tablet BID for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One matching placebo tablet BID for 7 days

    Number of subjects in period 1
    		Gefapixant 45 mg BID Placebo BID
    Started
    23
    23
    Completed
    23
    23

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Gefapixant 45 mg BID
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.

    Reporting group title
    Placebo BID
    Reporting group description
    		 Participants received a matching placebo tablet BID for 7 days.

    Reporting group values
    		 Gefapixant 45 mg BID Placebo BID Total
    Number of subjects
    		 23 23 46
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 24.9 ± 7.4 24.3 ± 5.6 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 4 4 8
        Male
    		 19 19 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 1 2
        White
    		 21 21 42
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Gefapixant 45 mg BID
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.

    Reporting group title
    Placebo BID
    Reporting group description
    		 Participants received a matching placebo tablet BID for 7 days.

    Primary: Awake Coughs per Hour on Day 3

    		 Close Top of page
    End point title
    		 Awake Coughs per Hour on Day 3
    End point description
    Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3. The analysis population for this end point included all randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with human rhinovirus type 16 (HRV-16).
    End point type
    Primary
    End point timeframe
    Day 3
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    19
    Units: Coughs per hour
        least squares mean (confidence interval 95%)
    2.38 (1.01 to 3.75)
    2.70 (1.21 to 4.19)
    Statistical analysis title
    		 Awake Coughs per Hour on Day 3
    Comparison groups
    Placebo BID v Gefapixant 45 mg BID
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.748
    Method
    		 Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.29
         upper limit
    		 1.66

    Secondary: Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3

    		 Close Top of page
    End point title
    		 Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3
    End point description
    The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (BL) and on Day 3. The analysis population for this end point included all randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    19
    Units: Scores on a scale
        least squares mean (confidence interval 95%)
    6.07 (1.79 to 10.35)
    5.08 (0.39 to 9.78)
    Statistical analysis title
    		 Chg from BL in Cough Severity VAS Score on Day 3
    Comparison groups
    Gefapixant 45 mg BID v Placebo BID
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.754
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.33
         upper limit
    		 7.3

    Secondary: Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3

    		 Close Top of page
    End point title
    		 Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3
    End point description
    The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3. The analysis population for this end point included all randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    19
    Units: Scores on a scale
        least squares mean (confidence interval 95%)
    2.71 (0.46 to 4.97)
    1.91 (-0.55 to 4.38)
    Statistical analysis title
    		 Chg from BL in CSD Score on Day 3
    Comparison groups
    Gefapixant 45 mg BID v Placebo BID
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.627
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 4.1

    Secondary: Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3

    		 Close Top of page
    End point title
    		 Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3
    End point description
    The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline (BL) and on Day 3. The analysis population for this end point included all randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    19
    Units: Scores on a scale
        least squares mean (confidence interval 95%)
    -0.26 (-0.51 to -0.01)
    -0.35 (-0.62 to -0.08)
    Statistical analysis title
    		 Chg from BL in LCQ-Acute Score on Day 3
    Comparison groups
    Gefapixant 45 mg BID v Placebo BID
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.631
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.45

    Secondary: Percentage of Participants Who Experienced One or More Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Experienced One or More Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The analysis population for this end point included all randomized participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 21 days
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    23
    Units: Percentage of participants
        number (not applicable)
    100
    95.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The analysis population for this end point included all randomized participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Gefapixant 45 mg BID Placebo BID
    Number of subjects analysed
    23
    23
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 21 days
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    MK-7264 45 mg BID
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet BID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a matching placebo tablet BID for 7 days.

    Serious adverse events
    		 MK-7264 45 mg BID Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-7264 45 mg BID Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 23 (100.00%)
    22 / 23 (95.65%)
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    10
    0
    Hypogeusia
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Medical device site erythema
         subjects affected / exposed
    16 / 23 (69.57%)
    17 / 23 (73.91%)
         occurrences all number
    16
    17
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Salivary hypersecretion
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 23 (86.96%)
    21 / 23 (91.30%)
         occurrences all number
    20
    22
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1

    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.
    This study was terminated because the data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.
    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-Sat Apr 20 10:21:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA