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    Clinical Trial Results:
    A Phase 2a, Proof of Concept, Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women with Moderate to Severe Endometriosis-related Pain

    Summary
    EudraCT number
    		 2018-001098-26
    Trial protocol
    		 ES   PL  
    Global end of trial date
    30 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2021
    First version publication date
    01 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-7264-034
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03654326
    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
    30 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily pelvic pain score (cyclic and non-cyclic, combined) during Treatment Cycle 2.
    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
    11 Sep 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
    Australia: 4
    Country: Number of subjects enrolled
    Chile: 6
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Puerto Rico: 20
    Country: Number of subjects enrolled
    Russian Federation: 53
    Country: Number of subjects enrolled
    Ukraine: 21
    Country: Number of subjects enrolled
    United States: 48
    Worldwide total number of subjects
    187
    EEA total number of subjects
    29
    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)
    187
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a baseline menstrual cycle (approximately 4 weeks) prior to randomization to either gefapixant or placebo.

    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
    Arm description
    		 Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
    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
    Gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles).

    Investigational medicinal product name
    Naproxen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen sodium 275 mg tablets taken orally as rescue medication for endometriosis-related pain, at dose prescribed by sites' principal investigator

    Arm title
    		 Placebo
    Arm description
    		 Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.
    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
    Placebo-matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles).

    Investigational medicinal product name
    Naproxen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen sodium 275 mg tablets taken orally as rescue medication for endometriosis-related pain, at dose prescribed by sites' principal investigator

    Number of subjects in period 1
    		Gefapixant Placebo
    Started
    94
    93
    Completed
    88
    87
    Not completed
    6
    6
         Consent withdrawn by subject
    5
    3
         Physician decision
    -
    1
         Unable to adhere to study schedule
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gefapixant
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Reporting group values
    		 Gefapixant Placebo Total
    Number of subjects
    		 94 93 187
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 94 93 187
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 34.5 ( 6.6 ) 34.8 ( 7.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 94 93 187
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 35 31 66
        Not Hispanic or Latino
    		 59 62 121
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 4 3 7
        White
    		 88 86 174
        More than one race
    		 1 4 5
        Unknown or Not Reported
    		 0 0 0
    Average Daily Pelvic Pain Score
    Pelvic pain severity was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The average of the daily pelvic pain scores entered in participants' electronic diaries (eDiaries) was calculated for the baseline cycle (approximately 28 days).
    Units: Scores on a Scale
        arithmetic mean (standard deviation)
    		 6.5 ( 1.0 ) 6.5 ( 1.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Gefapixant
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Primary: Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2

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    End point title
    		 Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
    End point description
    Pelvic pain (cyclic pain associated with menses, and non-cyclic pain not associated with menses) severity score was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The averages of the daily pelvic pain scores (cyclic and non-cyclic, combined) entered in participants' electronic diaries (eDiaries) were calculated for Baseline and Treatment Cycle 2 (approximately Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline. The population analyzed included all randomized participants who received at least one dose of double-blind study intervention and had at least one day of eDiary entries during the post-randomization treatment cycle.
    End point type
    Primary
    End point timeframe
    Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
    End point values
    		 Gefapixant Placebo
    Number of subjects analysed
    94
    93
    Units: Scores on a Scale
        least squares mean (confidence interval 95%)
    -2.2 (-2.79 to -1.62)
    -1.7 (-2.30 to -1.13)
    Statistical analysis title
    		 Difference in Least Squares Mean
    Comparison groups
    Gefapixant v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.066 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 0.03
    Notes
    [1] - Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates

    Primary: Percentage of Participants Who Experienced an Adverse Event

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    End point title
    		 Percentage of Participants Who Experienced an Adverse Event
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, this analysis included AEs reported up to 14 days after end of study intervention (up to approximately 10 weeks). The population analyzed included all randomized participants who received at least one dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to approximately 10 weeks
    End point values
    		 Gefapixant Placebo
    Number of subjects analysed
    94
    93
    Units: Percentage of Participants
        number (not applicable)
    53.2
    35.5
    Statistical analysis title
    		 Difference in Percentage of Participants
    Comparison groups
    Gefapixant v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    17.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 31.3
    Notes
    [2] - Based on Miettinen & Nurminen method

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The population analyzed included all randomized participants who received at least one dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to approximately 8 weeks
    End point values
    		 Gefapixant Placebo
    Number of subjects analysed
    94
    93
    Units: Percentage of Participants
        number (not applicable)
    3.2
    0
    Statistical analysis title
    		 Difference in Percentage of Participants
    Comparison groups
    Gefapixant v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 9
    Notes
    [3] - Based on Miettinen & Nurminen method.

    Secondary: Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2

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    End point title
    		 Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
    End point description
    Cyclic pelvic pain (associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the daily cyclic pelvic pain scores entered in participants' eDiaries was calculated for Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline. The population analyzed included all randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available cyclic pelvic pain score data.
    End point type
    Secondary
    End point timeframe
    Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
    End point values
    		 Gefapixant Placebo
    Number of subjects analysed
    89
    90
    Units: Scores on a Scale
        least squares mean (confidence interval 95%)
    -2.0 (-2.55 to -1.35)
    -1.3 (-1.94 to -0.73)
    Statistical analysis title
    		 Difference in Least Squares Mean
    Comparison groups
    Gefapixant v Placebo
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.06
    Notes
    [4] - The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates

    Secondary: Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2

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    End point title
    		 Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
    End point description
    Non-cyclic pelvic pain (not associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the non-cyclic daily pelvic pain scores entered in participants' eDiaries was calculated for the Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates decrease in pain severity from baseline. The population analyzed included all randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available non-cyclic pelvic pain score data.
    End point type
    Secondary
    End point timeframe
    Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
    End point values
    		 Gefapixant Placebo
    Number of subjects analysed
    91
    90
    Units: Scores on a Scale
        least squares mean (confidence interval 95%)
    -2.3 (-2.90 to -1.69)
    -1.8 (-2.40 to -1.18)
    Statistical analysis title
    		 Difference in Least Squares Mean
    Comparison groups
    Gefapixant v Placebo
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 0.03
    Notes
    [5] - The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Up to approximately 24 weeks Serious adverse events and non-serious adverse events: Up to approximately 12 weeks
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Gefapixant
    Reporting group description
    		 Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain.

    Serious adverse events
    		 Gefapixant Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 93 (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
    		 Gefapixant Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 94 (38.30%)
    12 / 93 (12.90%)
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    9 / 94 (9.57%)
    1 / 93 (1.08%)
         occurrences all number
    9
    1
    Dysgeusia
         subjects affected / exposed
    15 / 94 (15.96%)
    2 / 93 (2.15%)
         occurrences all number
    16
    2
    Headache
         subjects affected / exposed
    4 / 94 (4.26%)
    7 / 93 (7.53%)
         occurrences all number
    4
    7
    Hypogeusia
         subjects affected / exposed
    5 / 94 (5.32%)
    0 / 93 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 94 (6.38%)
    0 / 93 (0.00%)
         occurrences all number
    6
    0
    Dry mouth
         subjects affected / exposed
    6 / 94 (6.38%)
    2 / 93 (2.15%)
         occurrences all number
    6
    2

    More information

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

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

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

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