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    Clinical Trial Results:
    A Dose Escalation Study to Assess the Efficacy and Tolerance of AF-219 in Subjects with Refractory Chronic Cough

    Summary
    EudraCT number
    		 2015-000474-35
    Trial protocol
    		 GB  
    Global end of trial date
    09 Feb 2016

    Results information
    Results version number
    		 v1
    This version publication date
    30 Jul 2017
    First version publication date
    30 Jul 2017
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    7264-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02349425
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Afferent study number: AF219-010, Merck study number: MK-7264-010
    Sponsors
    Sponsor organisation name
    Afferent Pharmaceuticals, Inc.
    Sponsor organisation address
    2929 Campus Dr #230, San Mateo, CA, United States, 94403
    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
    09 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose-response of Gefapixant (AF-219) in reducing Awake Objective Cough Frequency and to identify tolerable dose(s) of Gefapixant that reduce Awake Objective Cough Frequency.
    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
    09 Mar 2015
    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 States: 59
    Worldwide total number of subjects
    59
    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)
    31
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited at 12 clinical trial sites in the United States.

    Pre-assignment
    Screening details
    		 Participants were women and men between 18 and 80 years of age inclusive who had refractory chronic cough for at least one year without any abnormality considered to be significantly contributing to the chronic cough in chest radiograph or computed tomography thorax.

    Period 1
    Period 1 title
    Period 1
    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
    		 Cohort 1: Gefapixant > Placebo
    Arm description
    		 50, 100, 150, or 200 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 50 mg, 100 mg, 150 mg, or 200 mg oral, administered as 1, 2, 3, or 4 50-mg tablets BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 1: Placebo > Gefapixant
    Arm description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 50, 100, 150, or 200 mg BID for 4 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 50 mg, 100 mg, 150 mg, or 200 mg oral, administered as 1, 2, 3, or 4 50-mg tablets BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 2: Gefapixant > Placebo
    Arm description
    		 7.5, 15, 30, or 50 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 7.5 mg, 15 mg, 30 mg, or 50 mg oral, administered as 1, 2, or 4 7.5-mg tablets or 1 50-mg tablet BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 2: Placebo > Gefapixant
    Arm description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 7.5, 15, 30, or 50 mg BID for 4 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 7.5 mg, 15 mg, 30 mg, or 50 mg oral, administered as 1, 2, or 4 7.5-mg tablets or 1 50-mg tablet BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Number of subjects in period 1
    		Cohort 1: Gefapixant > Placebo Cohort 1: Placebo > Gefapixant Cohort 2: Gefapixant > Placebo Cohort 2: Placebo > Gefapixant
    Started
    15
    14
    15
    15
    Completed
    14
    13
    15
    15
    Not completed
    1
    1
    0
    0
         Adverse event, non-fatal
    1
    1
    -
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Gefapixant > Placebo
    Arm description
    		 50, 100, 150, or 200 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 50 mg, 100 mg, 150 mg, or 200 mg oral, administered as 1, 2, 3, or 4 50-mg tablets BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 1: Placebo > Gefapixant
    Arm description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 50, 100, 150, or 200 mg BID for 4 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 50 mg, 100 mg, 150 mg, or 200 mg oral, administered as 1, 2, 3, or 4 50-mg tablets BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 2: Gefapixant > Placebo
    Arm description
    		 7.5, 15, 30, or 50 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 7.5 mg, 15 mg, 30 mg, or 50 mg oral, administered as 1, 2, or 4 7.5-mg tablets or 1 50-mg tablet BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Arm title
    		 Cohort 2: Placebo > Gefapixant
    Arm description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 7.5, 15, 30, or 50 mg BID for 4 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefapixant
    Investigational medicinal product code
    Other name
    AF-219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefapixant: 7.5 mg, 15 mg, 30 mg, or 50 mg oral, administered as 1, 2, or 4 7.5-mg tablets or 1 50-mg tablet BID for 4 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Gefapixant, oral, administered BID for 16 days

    Number of subjects in period 2
    		Cohort 1: Gefapixant > Placebo Cohort 1: Placebo > Gefapixant Cohort 2: Gefapixant > Placebo Cohort 2: Placebo > Gefapixant
    Started
    14
    13
    15
    15
    Completed
    14
    12
    14
    15
    Not completed
    0
    1
    1
    0
         Adverse event, non-fatal
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 59 59
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.7 ( 9.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 49 49
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Gefapixant > Placebo
    Reporting group description
    		 50, 100, 150, or 200 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Reporting group title
    Cohort 1: Placebo > Gefapixant
    Reporting group description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 50, 100, 150, or 200 mg BID for 4 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Reporting group title
    Cohort 2: Gefapixant > Placebo
    Reporting group description
    		 7.5, 15, 30, or 50 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Reporting group title
    Cohort 2: Placebo > Gefapixant
    Reporting group description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 7.5, 15, 30, or 50 mg BID for 4 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.
    Reporting group title
    Cohort 1: Gefapixant > Placebo
    Reporting group description
    		 50, 100, 150, or 200 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Reporting group title
    Cohort 1: Placebo > Gefapixant
    Reporting group description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 50, 100, 150, or 200 mg BID for 4 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Reporting group title
    Cohort 2: Gefapixant > Placebo
    Reporting group description
    		 7.5, 15, 30, or 50 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Reporting group title
    Cohort 2: Placebo > Gefapixant
    Reporting group description
    		 Placebo BID for 16 days in Period 1 and Gefapixant 7.5, 15, 30, or 50 mg BID for 4 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Subject analysis set title
    Cohort 1: Gefapixant 50 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant: 50 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Placebo to Gefapixant 50 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 50 mg BID for 4 days in Period 1 or Period 2

    Subject analysis set title
    Cohort 1: Gefapixant 100 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant: 100 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Placebo to Gefapixant 100 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 100 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Gefapixant 150 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant 150 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Placebo to AF-219 150 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to AF-219 150 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Gefapixant 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant 200 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1: Placebo to Gefapixant 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 200 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Gefapixant 7.5 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant 7.5 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Placebo to Gefapixant 7.5 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 7.5 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Gefapixant 15 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant 15 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Placebo to Gefapixant 15 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 15 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Gefapixant 30 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant 30 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Placebo to Gefapixant 30 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 30 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Gefapixant 50 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant: 50 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 2: Placebo to Gefapixant 50 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant 50 mg BID for 4 days in Period 1 or Period 2.

    Subject analysis set title
    Cohort 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    50, 100, 150, or 200 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods. Placebo BID for 16 days in Period 1 and Gefapixant 50, 100, 150, or 200 mg BID for 4 days in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Subject analysis set title
    Cohort 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    7.5, 15, 30, or 50 mg Gefapixant BID for 4 days in Period 1 and placebo BID for 16 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods. Placebo BID for 16 days in Period 1 and Gefapixant 7.5, 15, 30, or 50 mg BID for 4 days in Period 2. For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Subject analysis set title
    Gefapixant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Gefapixant: 50 mg/100 mg/150 mg/200 mg (all BID for 4 days in Period 1 or Period 2). For Cohort 1, there was a 3 to 7 day washout period between treatment periods. Gefapixant: 7.5 mg/15 mg/30 mg/50 mg (all BID for 4 days in Period 1 or Period 2). For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo to Gefapixant (BID for 16 days). For Cohort 1, there was a 3 to 7 day washout period between treatment periods. Placebo to Gefapixant (BID for 16 days). For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Subject analysis set title
    Cohort 1 - Gefapixant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive Gefapixant: 50 mg/100 mg/150 mg/200 mg (all BID for 4 days in Period 1 or Period 2). For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Subject analysis set title
    Cohort 1 - Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive Placebo to Gefapixant (BID for 16 days). For Cohort 1, there was a 3 to 7 day washout period between treatment periods.

    Subject analysis set title
    Cohort 2 - Gefapixant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive Gefapixant: 7.5 mg/15 mg/30 mg/50 mg (all BID for 4 days in Period 1 or Period 2). For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Subject analysis set title
    Cohort 2- Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive Placebo to Gefapixant (BID for 16 days). For Cohort 2, there was a 14 to 21 day washout period between treatment periods.

    Primary: Change from Baseline in Awake Cough Frequency for Cohort 1

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    End point title
    		 Change from Baseline in Awake Cough Frequency for Cohort 1 [1]
    End point description
    Awake Objective Frequency (per hour) = The total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the awake objective cough frequency endpoint for Cohort 1.
    End point type
    Primary
    End point timeframe
    24 hours (while awake) on Days 0 and 22 (Baseline) and 24 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    26
    25
    24
    25
    23
    22
    25
    25
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -26.5 ( 37.79 )
    -0.4 ( 12.53 )
    -29.2 ( 39.11 )
    -0.4 ( 15.51 )
    -25.2 ( 38.39 )
    4.3 ( 20.37 )
    -26.2 ( 40.75 )
    4 ( 22.56 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Awake Cough Frequency for Cohort 2

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    End point title
    		 Change from Baseline in Awake Cough Frequency for Cohort 2 [2]
    End point description
    Awake Objective Frequency (per hour) = The total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized subjects who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline primary endpoint observation for the awake objective cough frequency endpoint for Cohort 2.
    End point type
    Primary
    End point timeframe
    24 hours (while awake) on Days 0 and 22 (Baseline) and 24 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    29
    28
    30
    29
    29
    29
    29
    27
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -11 ( 31.62 )
    -2.6 ( 16.47 )
    -14.9 ( 30.59 )
    -4.7 ( 12.24 )
    -23.9 ( 37.99 )
    2.1 ( 16.71 )
    -24.3 ( 35.48 )
    1.1 ( 23.39 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Awake Cough Frequency for Cohort 1

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    End point title
    		 Percent Change from Baseline in Awake Cough Frequency for Cohort 1 [3]
    End point description
    Awake Objective Frequency (per hour) = The total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the awake objective cough frequency endpoint for Cohort 1.
    End point type
    Primary
    End point timeframe
    24 hours (while awake) on Days 0 and 22 (Baseline) and 24 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    26
    25
    24
    25
    23
    22
    25
    25
    Units: Percent Change
        arithmetic mean (standard deviation)
    -20.6 ( 84.29 )
    -0.1 ( 33.75 )
    -31.7 ( 70.27 )
    1.9 ( 35.18 )
    -22 ( 82.84 )
    -0.1 ( 39.55 )
    -27.9 ( 57.03 )
    15.1 ( 48.38 )
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in Awake Cough Frequency - Cohort 2

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    End point title
    		 Percent Change from Baseline in Awake Cough Frequency - Cohort 2 [4]
    End point description
    Awake Objective Frequency (per hour) = The total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the awake objective cough frequency endpoint for Cohort 2.
    End point type
    Primary
    End point timeframe
    24 hours (while awake) on Days 0 and 22 (Baseline) and 24 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    29
    28
    30
    29
    29
    29
    29
    27
    Units: Percent Change
        arithmetic mean (standard deviation)
    5 ( 125.05 )
    -3.8 ( 36.13 )
    -21.4 ( 39.32 )
    -6.4 ( 33.78 )
    -26.3 ( 61.01 )
    -1.1 ( 64.38 )
    -28.1 ( 74.9 )
    23.1 ( 92.6 )
    No statistical analyses for this end point

    Primary: Baseline (Predose) Awake Cough Frequency for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) Awake Cough Frequency for Cohort 1 and Cohort 2 [5]
    End point description
    Awake Objective Frequency (per hour) = The total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline observation for the awake objective cough frequency endpoint for Cohort 1.
    End point type
    Primary
    End point timeframe
    24 hours (while awake) on Days 0 and 22 (Baseline)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    26
    30
    29
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    54.5 ( 41.09 )
    52.8 ( 40.44 )
    49.6 ( 44.01 )
    46.1 ( 39.82 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total (24-hour) Cough Frequency - Cohort 1

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    End point title
    		 Change from Baseline in Total (24-hour) Cough Frequency - Cohort 1
    End point description
    Total (0 - 24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours) for the monitoring period. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough frequency endpoint for Cohort 1.
    End point type
    Secondary
    End point timeframe
    24 hours on Days 0 and 22 (Baseline) and 24 hours after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    26
    25
    24
    25
    23
    22
    25
    25
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -18.4 ( 25.77 )
    -0.7 ( 10.76 )
    -19.3 ( 27.83 )
    -0.1 ( 10.5 )
    -17.2 ( 26.27 )
    3.2 ( 16.21 )
    -18.1 ( 29.98 )
    4 ( 17.03 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Awake (0 - 8 hours) Cough Frequency - Cohort 1

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    End point title
    		 Change from Baseline in Awake (0 - 8 hours) Cough Frequency - Cohort 1
    End point description
    Awake (0 - 8 hours) Objective Cough Frequency = Total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24 hour sound recordings were collected with a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the awake cough frequency endpoint for Cohort 1.
    End point type
    Secondary
    End point timeframe
    First 8 hours (while awake) on Days 0 and 22 (Baseline) and the first 8 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    26
    25
    24
    25
    23
    22
    25
    25
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -25.8 ( 38.89 )
    -5.1 ( 17.55 )
    -27 ( 35.85 )
    0.5 ( 15.16 )
    -23.3 ( 37.95 )
    4.8 ( 28.43 )
    -28.4 ( 39.76 )
    2.9 ( 23.02 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sleep Cough Frequency - Cohort 1

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    End point title
    		 Change from Baseline in Sleep Cough Frequency - Cohort 1
    End point description
    Sleep Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24 hour sound recording were collected with a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the sleep cough frequency endpoint for Cohort 1.
    End point type
    Secondary
    End point timeframe
    24 hours (while asleep) on Days 0 and 22 (Baseline) and 24 hours (while asleep) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    24
    24
    21
    24
    22
    22
    24
    25
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -3.8 ( 8.66 )
    -0.2 ( 13.23 )
    -3.3 ( 11.86 )
    -1.1 ( 8.6 )
    -1.6 ( 6.54 )
    0.1 ( 6.96 )
    -3.2 ( 9.62 )
    0.2 ( 10.17 )
    No statistical analyses for this end point

    Secondary: Change from Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1

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    End point title
    		 Change from Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1
    End point description
    The daily CSD instrument has a total of 7 items (daily cough frequency, daily number of coughing fits or episodes, daily number of urges to cough, daily cough harshness score, daily cough physical discomfort score, daily level of disruption of activities due to cough, daily level of sleep disruption due to cough, in the instrument, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score is the sum of these 7 item scores. Mean total daily CSD score for each dose period is defined as the average of the total daily scores for the corresponding dose period. Baseline CSD score is defined as the average of CSD scores at screening and baseline. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough severity diary endpoint for Cohort 1.
    End point type
    Secondary
    End point timeframe
    Baseline (Days 0 and 22) and daily during the treatment period (up to Day 39)
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    28
    28
    27
    27
    26
    27
    26
    27
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -0.7 ( 1.56 )
    0 ( 1.1 )
    -1.1 ( 2.21 )
    0.2 ( 1.35 )
    -1.5 ( 2.38 )
    0.1 ( 1.49 )
    -1.6 ( 2.7 )
    0.1 ( 1.54 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2

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    End point title
    		 Change from Baseline in the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2
    End point description
    The LCQ instrument has 3 domains in the LCQ instrument: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, and 19). For each domain, the domain score (range 1 - 7) is the sum of individual item score within the domain divided by the number of items in the domain; total LCQ score (range 3-21) is the sum of the 3 domain scores. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for LCQ instrument endpoint.
    End point type
    Secondary
    End point timeframe
    Days 0 and 22 (Baseline) and Days 17 and 39
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    27
    28
    30
    29
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Psychological Domain Score
    1.2 ( 1.63 )
    -0.2 ( 1.13 )
    1.2 ( 1.7 )
    0.1 ( 1.01 )
        Physical Domain Score
    0.9 ( 1.45 )
    -0.4 ( 0.91 )
    1 ( 1.35 )
    0.1 ( 1 )
        Social Domain Score
    0.9 ( 1.69 )
    -0.3 ( 1.21 )
    1.4 ( 1.69 )
    -0.1 ( 0.94 )
        Total Acute Leicester Score
    3 ( 4.35 )
    -0.8 ( 2.74 )
    3.6 ( 4.44 )
    0.1 ( 2.48 )
    No statistical analyses for this end point

    Secondary: Change from Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 1

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    End point title
    		 Change from Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 1
    End point description
    Cough VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm. Baseline cough VAS is defined as average of screening and baseline cough VAS. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough VAS scores for Cohort 1.
    End point type
    Secondary
    End point timeframe
    Screening, Days 0 and 22 (Baseline), and Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 1: Gefapixant 50 mg Cohort 1: Placebo to Gefapixant 50 mg Cohort 1: Gefapixant 100 mg Cohort 1: Placebo to Gefapixant 100 mg Cohort 1: Gefapixant 150 mg Cohort 1: Placebo to AF-219 150 mg Cohort 1: Gefapixant 200 mg Cohort 1: Placebo to Gefapixant 200 mg
    Number of subjects analysed
    27
    28
    27
    27
    26
    27
    26
    27
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -14.5 ( 27.53 )
    -3.8 ( 16.14 )
    -26.3 ( 31.36 )
    -6 ( 17.37 )
    -28.2 ( 31.93 )
    -2.1 ( 23.26 )
    -30.8 ( 32.15 )
    2.7 ( 22.03 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total (24-hour) Cough Frequency - Cohort 2

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    End point title
    		 Change from Baseline in Total (24-hour) Cough Frequency - Cohort 2
    End point description
    Total (0 - 24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours) for the monitoring period. 24 hour sound recordings were collected at Baseline (Day 0) and on Days 4, 8, 12, 16, 22, 26, 30, 34, and 38 using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough frequency endpoint for Cohort 2.
    End point type
    Secondary
    End point timeframe
    24 hours on Days 0 and 22 (Baseline) and 24 hours after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    29
    28
    30
    29
    29
    29
    29
    27
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -7.6 ( 23.55 )
    -1.6 ( 11.88 )
    -11.4 ( 21.15 )
    -2.8 ( 10.43 )
    -17.5 ( 27.88 )
    2.3 ( 10.56 )
    -16.7 ( 24.84 )
    2.7 ( 16.48 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Awake (0 - 8 hours) Cough Frequency - Cohort 2

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    End point title
    		 Change from Baseline in Awake (0 - 8 hours) Cough Frequency - Cohort 2
    End point description
    Awake (0 - 8 hours) Objective Cough Frequency = Total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the awake cough frequency endpoint for Cohort 2.
    End point type
    Secondary
    End point timeframe
    First 8 hours (while awake) on Days 0 and 22 (Baseline) and the first 8 hours (while awake) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    29
    28
    30
    29
    29
    29
    29
    27
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -8.5 ( 34.52 )
    0.2 ( 24.54 )
    -15.7 ( 29.03 )
    -0.5 ( 17.07 )
    -22.4 ( 37.68 )
    9.5 ( 23.58 )
    -22.8 ( 38.88 )
    6.3 ( 30.58 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sleep Cough Frequency - Cohort 2

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    End point title
    		 Change from Baseline in Sleep Cough Frequency - Cohort 2
    End point description
    Sleep Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the sleep cough frequency endpoint for Cohort 2.
    End point type
    Secondary
    End point timeframe
    24 hours (while asleep) on Days 0 and 22 (Baseline) and 24 hours (while asleep) after dosing on Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    29
    28
    30
    29
    29
    29
    28
    27
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    -1.2 ( 22.56 )
    1.2 ( 8.44 )
    -4.6 ( 25.04 )
    -0.6 ( 4.61 )
    -4.2 ( 21.38 )
    0.2 ( 5.14 )
    -4.4 ( 24.38 )
    4.1 ( 17.08 )
    No statistical analyses for this end point

    Secondary: Change from Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 2

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    End point title
    		 Change from Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 2
    End point description
    The daily CSD instrument has a total of 7 items (daily cough frequency, daily number of coughing fits or episodes, daily number of urges to cough, daily cough harshness score, daily cough physical discomfort score, daily level of disruption of activities due to cough, daily level of sleep disruption due to cough, in the instrument, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score is the sum of these 7 item scores. Mean total daily CSD score for each dose period is defined as the average of the total daily scores for the corresponding dose period. Baseline CSD score is defined as the average of CSD scores at screening and baseline. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough severity diary endpoint for Cohort 2.
    End point type
    Secondary
    End point timeframe
    Baseline (Days 0 and 22) and daily during the treatment period (up to Day 39)
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    30
    28
    30
    28
    30
    28
    29
    28
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1 ( 1.41 )
    -0.3 ( 1.13 )
    -1.2 ( 1.78 )
    -0.3 ( 1.4 )
    -1.7 ( 2.12 )
    -0.4 ( 0.88 )
    -1.6 ( 2.55 )
    -0.6 ( 1.22 )
    No statistical analyses for this end point

    Secondary: Change from Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 2

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    End point title
    		 Change from Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 2
    End point description
    Cough VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm. Baseline cough VAS is defined as average of screening and baseline cough VAS. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline and at least 1 post baseline endpoint observation for the cough VAS scores for Cohort 2.
    End point type
    Secondary
    End point timeframe
    Screening, Days 0 and 22 (Baseline), and Days 4, 8, 12, 16, 26, 30, 34, and 38
    End point values
    		 Cohort 2: Gefapixant 7.5 mg Cohort 2: Placebo to Gefapixant 7.5 mg Cohort 2: Gefapixant 15 mg Cohort 2: Placebo to Gefapixant 15 mg Cohort 2: Gefapixant 30 mg Cohort 2: Placebo to Gefapixant 30 mg Cohort 2: Gefapixant 50 mg Cohort 2: Placebo to Gefapixant 50 mg
    Number of subjects analysed
    30
    29
    30
    29
    30
    29
    29
    29
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -12.6 ( 23.49 )
    -6.4 ( 23.07 )
    -17.4 ( 26.32 )
    -9.9 ( 20.01 )
    -23.3 ( 29.81 )
    -7.7 ( 12.91 )
    -24.9 ( 35.69 )
    -9.3 ( 19.04 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) Total (24-hour) Cough Frequency for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) Total (24-hour) Cough Frequency for Cohort 1 and Cohort 2
    End point description
    Total (0 - 24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours) for the monitoring period. 24 hour sound recordings were collected using a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline endpoint observation for the cough frequency endpoint for Cohort 1 and for Cohort 2.
    End point type
    Secondary
    End point timeframe
    24 hours on Days 0 and 22 (Baseline)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    26
    30
    29
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    39.7 ( 28.38 )
    37.9 ( 27.46 )
    36.3 ( 32.28 )
    32.2 ( 27.97 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) Awake (0 - 8 hours) Cough Frequency for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) Awake (0 - 8 hours) Cough Frequency for Cohort 1 and Cohort 2
    End point description
    Awake (0 - 8 hours) Objective Cough Frequency = Total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24 hour sound recordings were collected with a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline for the awake cough frequency endpoint for Cohort 1 and Cohort 2.
    End point type
    Secondary
    End point timeframe
    First 8 hours (while awake) on Days 0 and 22 (Baseline)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    26
    30
    29
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    51.8 ( 41.09 )
    53.3 ( 42.3 )
    47.2 ( 42.09 )
    42.2 ( 39.42 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) for Sleep Cough Frequency for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) for Sleep Cough Frequency for Cohort 1 and Cohort 2
    End point description
    Sleep Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24 hour sound recording were collected with a digital recording device. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline for the sleep cough frequency endpoint for Cohort 1 and Cohort 2
    End point type
    Secondary
    End point timeframe
    24 hours (while asleep) on Days 0 and 22 (Baseline)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    27
    26
    30
    29
    Units: Coughs/hour
        arithmetic mean (standard deviation)
    8.3 ( 9.3 )
    7.8 ( 9.8 )
    10.1 ( 26.77 )
    5.6 ( 7.58 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) for the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) for the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1 and Cohort 2
    End point description
    The daily CSD instrument has a total of 7 items (daily cough frequency, daily number of coughing fits or episodes, daily number of urges to cough, daily cough harshness score, daily cough physical discomfort score, daily level of disruption of activities due to cough, daily level of sleep disruption due to cough, in the instrument, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score is the sum of these 7 item scores. Mean total daily CSD score for each dose period is defined as the average of the total daily scores for the corresponding dose period. Baseline CSD score is defined as the average of CSD scores at screening and baseline. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline for the cough severity diary endpoint for Cohort 1 and Cohort 2.
    End point type
    Secondary
    End point timeframe
    Baseline (Days 0 and 22)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    28
    30
    28
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    4.2 ( 1.89 )
    3.7 ( 1.61 )
    4.5 ( 1.98 )
    4.5 ( 1.93 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2
    End point description
    The LCQ instrument has 3 domains in the LCQ instrument: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, and 19). For each domain, the domain score (range 1 - 7) is the sum of individual item score within the domain divided by the number of items in the domain; total LCQ score (range 3-21) is the sum of the 3 domain scores. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline observation for the LCQ instrument endpoint for Cohort 1 and Cohort 2.
    End point type
    Secondary
    End point timeframe
    Days 0 and 22 (Baseline)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    28
    30
    29
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Psychological Domain Score
    3.8 ( 1.21 )
    4.1 ( 1.45 )
    3.9 ( 1.57 )
    4.1 ( 1.56 )
        Physical Domain Score
    4.4 ( 0.99 )
    4.7 ( 1.06 )
    4.8 ( 1.19 )
    5 ( 1 )
        Social Domain Score
    4.2 ( 1.22 )
    4.3 ( 1.21 )
    3.9 ( 1.57 )
    4.2 ( 1.57 )
        Total Acute Leicester Score
    12.3 ( 3.13 )
    13.1 ( 3.41 )
    12.6 ( 4.04 )
    13.3 ( 3.81 )
    No statistical analyses for this end point

    Secondary: Baseline (Predose) for Cough Visual analogue Scale (VAS) for Cohort 1 and Cohort 2

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    End point title
    		 Baseline (Predose) for Cough Visual analogue Scale (VAS) for Cohort 1 and Cohort 2
    End point description
    Cough VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm. Baseline cough VAS is defined as average of screening and baseline cough VAS. The analysis population consisted of all randomized participants who took at least 1 dose of study medication and provided at least 1 baseline observation for the cough VAS score for Cohort 1 and Cohort 2.
    End point type
    Secondary
    End point timeframe
    Screening, Days 0 and 22 (Baseline)
    End point values
    		 Cohort 1 - Gefapixant Cohort 1 - Placebo Cohort 2 - Gefapixant Cohort 2- Placebo
    Number of subjects analysed
    28
    28
    30
    29
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    58.4 ( 18.66 )
    52.2 ( 19.21 )
    54.5 ( 24.26 )
    57.2 ( 23.71 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 days
    Adverse event reporting additional description
    Adverse events (AE) are attributed to the treatment that a participant was receiving at the onset of the AE. Adverse events were attributed only to the treatment that the participant was receiving at the time of onset of the AE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cohort 1 Gefapixant 50 mg
    Reporting group description
    		 Gefapixant: 50 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 1 Gefapixant 100 mg
    Reporting group description
    		 Gefapixant: 100 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 1 Gefapixant 150 mg
    Reporting group description
    		 Gefapixant 150 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 1 Gefapixant 200 mg
    Reporting group description
    		 Gefapixant 200 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 1 Placebo
    Reporting group description
    		 Participants randomized to receive Placebo to Gefapixant (BID for 16 days) in Period 1 or Period 2.

    Reporting group title
    Cohort 2 Gefapixant 7.5 mg
    Reporting group description
    		 Gefapixant 7.5 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 2 Gefapixant 15 mg
    Reporting group description
    		 Gefapixant 15 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 2 Gefapixant 30 mg
    Reporting group description
    		 Gefapixant 30 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 2 Gefapixant 50 mg
    Reporting group description
    		 Gefapixant: 50 mg BID for 4 days in Period 1 or Period 2.

    Reporting group title
    Cohort 2 Placebo
    Reporting group description
    		 Participants randomized to receive Placebo to Gefapixant (BID for 16 days) in Period 1 or Period 2.

    Serious adverse events
    		 Cohort 1 Gefapixant 50 mg Cohort 1 Gefapixant 100 mg Cohort 1 Gefapixant 150 mg Cohort 1 Gefapixant 200 mg Cohort 1 Placebo Cohort 2 Gefapixant 7.5 mg Cohort 2 Gefapixant 15 mg Cohort 2 Gefapixant 30 mg Cohort 2 Gefapixant 50 mg Cohort 2 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Gefapixant 50 mg Cohort 1 Gefapixant 100 mg Cohort 1 Gefapixant 150 mg Cohort 1 Gefapixant 200 mg Cohort 1 Placebo Cohort 2 Gefapixant 7.5 mg Cohort 2 Gefapixant 15 mg Cohort 2 Gefapixant 30 mg Cohort 2 Gefapixant 50 mg Cohort 2 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    8 / 28 (28.57%)
    4 / 26 (15.38%)
    6 / 26 (23.08%)
    4 / 28 (14.29%)
    6 / 30 (20.00%)
    1 / 30 (3.33%)
    13 / 30 (43.33%)
    9 / 30 (30.00%)
    2 / 29 (6.90%)
    Investigations
    Urine output decreased
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Dysgeusia
         subjects affected / exposed
    13 / 28 (46.43%)
    6 / 28 (21.43%)
    4 / 26 (15.38%)
    1 / 26 (3.85%)
    1 / 28 (3.57%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    12 / 30 (40.00%)
    4 / 30 (13.33%)
    0 / 29 (0.00%)
         occurrences all number
    13
    6
    4
    1
    1
    2
    1
    12
    4
    0
    Hypogeusia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    2
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    1
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    2
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal dryness
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    2 / 26 (7.69%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    4 / 30 (13.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    4
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 28 (7.14%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2015
    Amendment 1: Low-Dose Cohort 2 with an additional 30 subjects was added to the trial.
    03 Sep 2015
    Amendment 2: Changes in study objectives and endpoints and elimination of study sites in the United Kingdom.
    02 Oct 2015
    Amendment 3: Changes made to Renal/Urologic Symptom Inventory assessments, wash-out periods, and the follow-up of adverse events.

    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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