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    Clinical Trial Results:
    A Phase 2a, Multi-Centre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Efficacy, Safety and Tolerability of Inhaled GRC 17536, Administered for 4 Weeks, in Patients with Refractory Chronic Cough

    Summary
    EudraCT number
    		 2013-002728-17
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Mar 2016
    First version publication date
    24 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • New data added to full data set
    Public contact name changed to Amol Pendse (Amol.Pendse@glenmarkpharma.com)

    Trial information

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    Trial identification
    Sponsor protocol code
    GRC17536-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glenmark Pharmaceuticals S.A
    Sponsor organisation address
    Chemin de la Combeta, 5, Ch-2300 , La Chaux-de-fonds, Switzerland,
    Public contact
    Amol Pendse, Glenmark Pharmaceuticals S.A, +91 2267720000, Amol.Pendse@glenmarkpharma.com
    Scientific contact
    Dr. Monika Tandon, Glenmark Pharmaceuticals S.A, +91 2267720000, Monika.Tandon@glenmarkpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of GRC 17536 on 24 hour cough frequency using the Leicester cough monitor (LCM) in patients with refractory chronic cough.
    Protection of trial subjects
    In the interests of subject safety and acceptable standards of medical care the Investigator was permitted to prescribe treatment(s) at his/her discretion. All treatments taken by the subjects during the study were recorded in the subjects’ CRF (medication, dose, treatment duration and indication).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2013
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    28
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first patient enrollment: 22 Nov 2013 Date of last patient completed: 30 Jul 2014 Country: United Kingdom

    Pre-assignment
    Screening details
    		 Screening period: 2 weeks, Patients with refractory chronic cough

    Period 1
    Period 1 title
    GRC 17536 Vs Placebo (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GRC 17536
    Arm description
    		 Dose: GRC 17536 10 mg BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: GRC 17536 will be orally-inhaled using a MIAT monodose inhaler.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    GRC 17536 10 mg BID (approximately 12 hr apart) for 28 days (Days 1 to 28).

    Arm title
    		 Placebo
    Arm description
    		 Dose: Placebo BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: Placebo will be orally-inhaled using a MIAT monodose inhaler.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo BID (approximately 12 hr. apart) for 28 days (Days 1 to 28).

    Number of subjects in period 1
    		GRC 17536 Placebo
    Started
    26
    26
    Completed
    23
    25
    Not completed
    3
    1
         Adverse event, non-fatal
    2
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GRC 17536
    Reporting group description
    		 Dose: GRC 17536 10 mg BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: GRC 17536 will be orally-inhaled using a MIAT monodose inhaler.

    Reporting group title
    Placebo
    Reporting group description
    		 Dose: Placebo BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: Placebo will be orally-inhaled using a MIAT monodose inhaler.

    Reporting group values
    		 GRC 17536 Placebo Total
    Number of subjects
    		 26 26 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        Adults (18-75 years)
    		 26 26 52
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.46 ± 9.07 63.08 ± 6.566 -
    Gender categorical
    Units: Subjects
        Female
    		 15 16 31
        Male
    		 11 10 21
    Subject analysis sets

    Subject analysis set title
    GRC 17536
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised of all randomized patients with at least one post-baseline assessment of the primary endpoint.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised of all randomized patients with at least one post-baseline assessment of the primary endpoint.

    Subject analysis sets values
    		 GRC 17536 Placebo
    Number of subjects
    23
    22
    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)
    0
    0
        From 65-84 years
    0
    0
        Adults (18-75 years)
    23
    22
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.51 ± 7.84
    62.94 ± 7.78
    Gender categorical
    Units: Subjects
        Female
    13
    13
        Male
    10
    9

    End points

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    End points reporting groups
    Reporting group title
    GRC 17536
    Reporting group description
    		 Dose: GRC 17536 10 mg BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: GRC 17536 will be orally-inhaled using a MIAT monodose inhaler.

    Reporting group title
    Placebo
    Reporting group description
    		 Dose: Placebo BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: Placebo will be orally-inhaled using a MIAT monodose inhaler.

    Subject analysis set title
    GRC 17536
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised of all randomized patients with at least one post-baseline assessment of the primary endpoint.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised of all randomized patients with at least one post-baseline assessment of the primary endpoint.

    Primary: Change in log 24 hour cough frequency from baseline to end of treatment between GRC 17536 and placebo

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    End point title
    		 Change in log 24 hour cough frequency from baseline to end of treatment between GRC 17536 and placebo
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 GRC 17536 Placebo
    Number of subjects analysed
    23
    22
    Units: Number
        log mean (standard deviation)
    -0.2 ± 0.397
    -0.21 ± 0.479
    Statistical analysis title
    		 Statistical Analysis of Primary Efficacy Endpoint
    Comparison groups
    GRC 17536 v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9804
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Dose: Placebo BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: Placebo will be orally-inhaled using a MIAT monodose inhaler.

    Reporting group title
    GRC 17536
    Reporting group description
    		 Dose: GRC 17536 10 mg BID (approximately 12 hr apart) for 28 days (Days 1 to 28 inclusive). Administration: GRC 17536 will be orally-inhaled using a MIAT monodose inhaler.

    Serious adverse events
    		 Placebo GRC 17536
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo GRC 17536
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 26 (61.54%)
    16 / 26 (61.54%)
    Investigations
    BLOOD GLUCOSE DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    RED BLOOD CELL SEDIMENTATION RATE INCREASED
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    HAEMATOCRIT DECREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    PLATELET COUNT INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    BLOOD UREA DECREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    URINE BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    URINE KETONE BODY PRESENT
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    PROTEIN URINE PRESENT
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    BILIRUBIN CONJUGATED INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    UROBILINOGEN URINE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    HAEMOPHILUS TEST POSITIVE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    HEADACHE
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 26 (19.23%)
         occurrences all number
    5
    7
    MIGRAINE
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    TENSION HEADACHE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    APHASIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    FATIGUE
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    CONJUNCTIVITIS ALLERGIC
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 26 (11.54%)
         occurrences all number
    1
    3
    VOMITING
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    DIARRHOEA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    DYSPNOEA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    COUGH
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    WHEEZING
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    BRONCHOSPASM
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    PRURITUS
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    DRUG ERUPTION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    ANXIETY
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    URINARY RETENTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    ARTHRALGIA
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    MYALGIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    RHINITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0

    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
    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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