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    Clinical Trial Results:
    Evaluation of orvepitant in an exploratory open-label clinical study in chronic treatment-refractory cough (The "VOLCANO-1" Study)

    Summary
    EudraCT number
    		 2014-003947-36
    Trial protocol
    		 GB  
    Global end of trial date
    26 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2017
    First version publication date
    18 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NT2014/Orv/Prot001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NeRRe Therapeutics Ltd
    Sponsor organisation address
    SBC, Incubator Building, Gunnels Wood Rd, Stevenage, United Kingdom, SG1 2FX
    Public contact
    Elizabeth Ballantyne, NeRRe Therapeutics Ltd, 44 07826 846960, Elizabeth.Ballantyne@nerretherapeutics.com
    Scientific contact
    Elizabeth Ballantyne, NeRRe Therapeutics Ltd, 44 07826 846960, Elizabeth.Ballantyne@nerretherapeutics.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
    22 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the change in objectively recorded daytime cough frequency in chronic treatment-refractory cough patients at Week 4 after treatment with orvepitant (30 mg given once daily [od], orally).
    Protection of trial subjects
    The study was conducted in adherence to ICH principles of Good Clinical Practice (GCP), as required by European Directive 2001/20/EC and 2005/28/EC and local rules relevant to the use of new therapeutic agents within the United Kingdom, and adherence to the general principles that have their origins in the Declaration of Helsinki. Subjects were provided with the Participant Information Sheet and Informed Consent Form for their prior review and approval before any study related procedures and subsequent participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 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 Kingdom: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    9
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Male and female subjects from 18 to 75 years with a diagnosis of chronic treatment-refractory cough based on a minimum of > 3 months of symptoms were enrolled on this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single-arm open-label study.

    Arms
    Arm title
    		 Orvepitant 30 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orvepitant 30 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg orvepitant was administered once daily for 4 weeks. Orvepitant was administered as oral tablets taken with or without food each day in the evening before bedtime.

    Number of subjects in period 1
    		Orvepitant 30 mg
    Started
    13
    Completed
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    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)
    		 9 9
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 60.1 (51 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Orvepitant 30 mg
    Reporting group description
    		 -

    Primary: Daytime cough frequency

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    End point title
    		 Daytime cough frequency [1]
    End point description
    Change in objective cough frequency at Week 4 compared to Baseline.
    End point type
    Primary
    End point timeframe
    Change at Week 4 compared to Baseline
    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: The EudraCT system only allows a statistical analysis result to be entered with at least 2 comparison groups. This was a single arm study. Comparison of objective daytime cough frequency at Week 4 compared to Baseline gave a Wald p-value of P<0.001.
    End point values
    		 Orvepitant 30 mg
    Number of subjects analysed
    13
    Units: N/A
        arithmetic mean (confidence interval 95%)
    -18.9 (-28.3 to -9.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from the time that the ICF was signed until the Follow-up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Orvepitant 30 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Orvepitant 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Orvepitant 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 13 (69.23%)
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Lethargy
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Periarthritis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    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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