Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, placebo-controlled, double-blind, parallel-group, multi-center, proof-of-concept study to assess the efficacy and safety of BAY 1817080 in patients with overactive bladder (OAB) over a 12-week treatment period

    Summary
    EudraCT number
    		 2019-002575-34
    Trial protocol
    		 CZ   SE   PL   PT   GB   DE   AT  
    Global end of trial date
    21 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2023
    First version publication date
    05 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BAY1817080/19733
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04545580
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30300139003, clinical-trials-contact@bayer.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
    18 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of eliapixant 125 mg twice a day (BID) in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2020
    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
    Austria: 2
    Country: Number of subjects enrolled
    Poland: 31
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Czechia: 31
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Portugal: 5
    Worldwide total number of subjects
    99
    EEA total number of subjects
    92
    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)
    60
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 28 centers in 9 countries with first subject first visit on 16-Sep-2020 and last subject last visit on 21-Jan-2022

    Pre-assignment
    Screening details
    		 Overall, 202 subjects were screened and 43 subjects failed screening. 159 subjects were assigned to run-in period, 59 of whom failed run-in. A total of 100 subjects were randomly assigned to 2 treatment arms (51 to eliapixant 125 mg BID and 49 to placebo). One subject in the placebo arm did not receive any study drug.

    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    During the run-in period, subjects were blinded for run-in treatment. Investigator and sponsor knew that subjects received run-in placebo treatment. After randomization, subject, investigator and sponsor were blinded to the identity of the randomized study intervention.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eliapixant 125mg BID
    Arm description
    		 Subjects received 125 mg oral doses of eliapixant, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant (BAY1817080)
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    125 mg twice daily (BID), administered orally for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Subjects received oral doses of placebo, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks
    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 twice daily (BID), administered orally for 12 weeks

    Number of subjects in period 1
    		Eliapixant 125mg BID Placebo
    Started
    51
    48
    Completed
    40
    41
    Not completed
    11
    7
         Consent withdrawn by subject
    -
    3
         Adverse event, non-fatal
    5
    -
         Pregnancy
    1
    -
         COVID-19 pandemic related
    -
    1
         Lack of efficacy
    4
    3
         Protocol deviation
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Eliapixant 125mg BID
    Reporting group description
    		 Subjects received 125 mg oral doses of eliapixant, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral doses of placebo, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks

    Reporting group values
    		 Eliapixant 125mg BID Placebo Total
    Number of subjects
    		 51 48 99
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 33 27 60
        From 65-84 years
    		 18 21 39
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.37 ( 10.74 ) 59.29 ( 14.32 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 40 81
        Male
    		 10 8 18
    Baseline mean number of UUI episodes per 24 hours
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: number of UUI episodes per 24 hours
        arithmetic mean (standard deviation)
    		 2.64 ( 2.11 ) 2.84 ( 1.98 ) -
    Baseline mean number of urinary incontinence (UI) episodes per 24 hours
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: number of UI episodes per 24 hours
        arithmetic mean (standard deviation)
    		 3.05 ( 2.29 ) 3.06 ( 2.11 ) -
    Baseline mean number of micturition episodes per24 hours
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: number of micturition episodes per 24 h
        arithmetic mean (standard deviation)
    		 11.98 ( 2.78 ) 10.83 ( 2.22 ) -
    Baseline mean number of urgency episodes (Grade 3 or 4) per 24 hours
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: number of urgency episodes per 24 hours
        arithmetic mean (standard deviation)
    		 5.94 ( 3.46 ) 5.63 ( 3.37 ) -
    Baseline mean number of nocturia episodes per 24 hours
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: number of nocturia episodes per 24 hours
        arithmetic mean (standard deviation)
    		 1.40 ( 0.96 ) 1.73 ( 0.94 ) -
    Baseline mean volume voided per micturition
    Used per protocol set (PPS): Eliapixant 125 mg BID (N=43), Placebo (N=42)
    Units: mL
        arithmetic mean (standard deviation)
    		 167.19 ( 71.61 ) 176.94 ( 68.31 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Eliapixant 125mg BID
    Reporting group description
    		 Subjects received 125 mg oral doses of eliapixant, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral doses of placebo, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomly assigned to the double-blind treatment and who took at least 1 dose of the double-blind study intervention were included in the SAF

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects randomly assigned to the double-blind treatment, who took at least 1 dose of the double-blind study intervention and for whom no validity finding was recorded were included in the PPS.

    Primary: Average change from baseline over Week 4, 8 and 12 (EoT) in mean number of UUI episodes per 24 hours based on electronic bladder diary

    		 Close Top of page
    End point title
    		 Average change from baseline over Week 4, 8 and 12 (EoT) in mean number of UUI episodes per 24 hours based on electronic bladder diary
    End point description
    Week 4: Eliapixant 125 mg BID (n=43), Placebo (n=41) Week 8: Eliapixant 125 mg BID (n=40), Placebo (n=42) Week 12: Eliapixant 125 mg BID (n=37), Placebo (n=34) An urgency urinary incontinence episode was defined as any urinary incontinence (UI) episode accompanied by urgency classified by the subject as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS).
    End point type
    Primary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    43 [1]
    42 [2]
    Units: number of UUI episodes per 24 hours
    arithmetic mean (standard deviation)
        Week 4
    -1.20 ( 1.25 )
    -1.31 ( 1.25 )
        Week 8
    -1.43 ( 1.51 )
    -1.68 ( 1.49 )
        Week 12
    -1.59 ( 1.35 )
    -1.60 ( 1.57 )
    Notes
    [1] - PPS
    [2] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible intervals were calculated. The posterior probability of eliapixant treatment resulting in a larger reduction of UUI episodes compared to placebo treatment over Week 4, 8 and 12 was 40.3%. According to the prespecified decision criterion, the targeted posterior probability of 90% could not be reached and no treatment effect could be obtained.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.046
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.377

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes per 24 hours

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes per 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [3]
    34 [4]
    Units: number of UUI episodes per 24 hours
        arithmetic mean (standard deviation)
    -1.59 ( 1.35 )
    -1.60 ( 1.57 )
    Notes
    [3] - PPS
    [4] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger reduction of UUI episodes compared to placebo at Week 12 was 45.5%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.469

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes per 24 hours

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes per 24 hours
    End point description
    A urinary incontinence episode was defined as the complaint of any involuntary leakage of urine. A urinary incontinence episode was also counted if a subject experienced an episode type of both micturition and incontinence.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [5]
    34 [6]
    Units: number of UI episodes per 24 hours
        arithmetic mean (standard deviation)
    -1.85 ( 1.61 )
    -1.75 ( 1.56 )
    Notes
    [5] - PPS
    [6] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger reduction of UI episodes compared to placebo at Week 12 was 49.8%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.001
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.473

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes per 24 hours

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes per 24 hours
    End point description
    A micturition episode was defined as any voluntary urination episode, excluding urinary incontinence only episodes. A micturition was also counted if a subject experienced an episode type of both micturition and incontinence.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [7]
    34 [8]
    Units: number of micturition episodes / 24 h
        arithmetic mean (standard deviation)
    -1.72 ( 2.14 )
    -1.20 ( 2.54 )
    Notes
    [7] - PPS
    [8] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger reduction of micturition episodes compared to placebo at Week 12 was 84.3%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.509
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.334

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4) per 24 hours

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4) per 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [9]
    34 [10]
    Units: number of urgency episodes per 24 hours
        arithmetic mean (standard deviation)
    -1.71 ( 2.94 )
    -2.03 ( 2.45 )
    Notes
    [9] - PPS
    [10] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger reduction of urgency episodes (Grade 3 or 4) compared to placebo at Week 12 was 40.3%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.134
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 1.049

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes per 24 hours

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes per 24 hours
    End point description
    Nocturia was the complaint that the subject woke up at night to void. In this study, it was defined as a micturition episode associated with sleep disturbance, between the time the subject went to bed with the intention to sleep until the time the subject woke up in the morning with the intention to stay awake.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [11]
    34 [12]
    Units: number of nocturia episodes per 24 hours
        arithmetic mean (standard deviation)
    -0.12 ( 0.84 )
    -0.18 ( 0.91 )
    Notes
    [11] - PPS
    [12] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger reduction of nocturia episodes compared to placebo at Week 12 was 51.6%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.007
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.271

    Secondary: Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition

    		 Close Top of page
    End point title
    		 Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
    End point description
    Volume voided per micturition was the urine volume measured for each reported micturition episode.
    End point type
    Secondary
    End point timeframe
    From baseline up to 12 weeks
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    37 [13]
    34 [14]
    Units: mL
        arithmetic mean (standard deviation)
    14.40 ( 43.63 )
    4.75 ( 43.36 )
    Notes
    [13] - PPS
    [14] - PPS
    Statistical analysis title
    		 Bayesian mixed model
    Statistical analysis description
    95% one sided upper credible interval was calculated. The posterior probability of eliapixant leading to a larger increase of volume voided per micturition compared to placebo at Week 12 was 75.9%.
    Comparison groups
    Eliapixant 125mg BID v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.29
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -8.324
         upper limit
    		 -

    Secondary: Number of subjects with adverse events (AE)

    		 Close Top of page
    End point title
    		 Number of subjects with adverse events (AE)
    End point description
    AE was defined as any untoward medical occurrence in a study subject, whether or not considered related to the study intervention, occurring from the start of study until the follow-up visit. A treatment-emergent adverse event (TEAE) was defined as any event arising or worsening after the start of randomized study intervention administration until 14 days after the last study intervention intake.
    End point type
    Secondary
    End point timeframe
    From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)
    End point values
    		 Eliapixant 125mg BID Placebo
    Number of subjects analysed
    51 [15]
    48 [16]
    Units: subject
        Any AE
    34
    29
        Maximum intensity for any AE: Mild
    18
    19
        Maximum intensity for any AE: Moderate
    14
    10
        Maximum intensity for any AE: Severe
    2
    0
        Any SAE
    1
    0
        Any AE resulting in discontinuation of drug
    6
    1
        Any TEAE
    32
    27
        Any study drug-related TEAE
    23
    9
        Any serious TEAE
    1
    0
        Any TEAE resulting in discontinuation of drug
    5
    1
    Notes
    [15] - SAF
    [16] - SAF
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks) Adverse event reporting for the deaths (all causes) considers all deaths that occurred at any time during the study before the last contact.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral doses of placebo, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks.

    Reporting group title
    Eliapixant 125 mg BID
    Reporting group description
    		 Subjects received 125 mg oral doses of eliapixant, administered twice daily at approximately the same time each day 12 hours apart over the course of 12 weeks.

    Serious adverse events
    		 Placebo Eliapixant 125 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Eliapixant 125 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 48 (60.42%)
    34 / 51 (66.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Hot flush
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 51 (7.84%)
         occurrences all number
    3
    5
    Oedema peripheral
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Thirst
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    General physical health deterioration
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Therapeutic product effect decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Prostatomegaly
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    3
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Amylase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 51 (3.92%)
         occurrences all number
    1
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    International normalised ratio increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Lipase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 51 (3.92%)
         occurrences all number
    1
    3
    Weight increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Nitrite urine present
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Lipase abnormal
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Transaminases increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Anosmia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Dizziness postural
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    2 / 48 (4.17%)
    5 / 51 (9.80%)
         occurrences all number
    2
    5
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    3
    3
    Hypogeusia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Taste disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Vertigo positional
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    5 / 48 (10.42%)
    2 / 51 (3.92%)
         occurrences all number
    5
    2
    Gastritis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Scab
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Skin irritation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Hypertonic bladder
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Urinary tract inflammation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Exostosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Obesity
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Decreased appetite
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2020
    • Exclusion criterion #15 was modified to exclude subjects with systolic/diastolic blood pressure levels ≥160/100 mmHg. • Positive hepatitis B and C were added in exclusion criterion #19. • Section on potential phototoxicity and instructions to avoid excessive exposure to sunlight were removed. • Text for the organic-anion-transporting polypeptide 1B1/1B3 (OATP1B1/1B3), breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp) substrates in Table 6-1 was revised. • Statistical considerations adjusted for coronavirus disease 2019 (COVID-19) related issues. • Additional information will also be recorded for smell-related AEs if reported spontaneously by the subject. • Anti-hepatitis D and E virus antibodies were added in the list of laboratory assessments for liver safety in case close observation is to be initiated. • Wording for non-specific symptoms which might be associated with liver dysfunction in Section 2.3.3.4 was revised and the pre-existing text in Section 10.6.2 was moved to Section 10.6.1. • Wording of repeated follow-up samplings was revised. • Stopping criteria for close liver observation was added. • Instructions were added that for study subjects who take biotin-containing supplements, the last dose of the supplement should be at least 72 hours prior to FSH hormone or ferritin testing. • Wording randomly assigned to “study intervention” was changed to randomly assigned to “double-blind treatment”. • Row for “mRNA (anti-HCV and HCV mRNA)” was deleted. • Anti-native double-stranded deoxyribonucleic acid (DNA) Antibodies was changed to “Anti-nuclear antibodies (ANA)” • “Anti-Smith antibodies” was changed to “anti-smooth muscle antibodies”. • Text for the increase of concentrations of total serum bilirubin in studies with healthy volunteers was removed. • Wordings of the primary, secondary and exploratory endpoints were updated. • Psychometric analyses of bladder diary were planned to be conducted alongside the statistic
    22 Jun 2021
    • Protocol version number was included in the Title page and removed from the header. Date is added in the header. • 2 new visits added for taking blood samples for liver monitoring. • Text updated regarding one case of moderate liver injury. • Text on blood samples for liver monitoring added. • Addition of extremely low body weight as an example to criterion #21.

    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA