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    Clinical Trial Results:
    Efficacy And Safety of Intranasal S0597 in Environmental Exposure Chamber Model of Seasonal Allergic Rhinitis: A Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study

    Summary
    EudraCT number
    		 2012-001613-16
    Trial protocol
    		 DE  
    Global end of trial date
    02 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2019
    First version publication date
    18 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SPARC_Ltd._CLR_12_03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sun Pharma Advanced Research Company Ltd.
    Sponsor organisation address
    17/B, Mahal Indudtries Limited, Mahakali Caves Road, Andheri, (East), Mumbai, India, 400 093
    Public contact
    Head- Clinical Development, Sun Pharma Advanced Research, +91 2266455645, clinical.trials@sparcmail.com
    Scientific contact
    Head-Clinical Development, Sun Pharma Advanced Research, +91 2266455645, clinical.trials@sparcmail.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 Mar 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess efficacy and safety of intranasal S0597 compared to placebo in alleviating the signs and symptoms of seasonal allergic rhinitis in environmental Exposure chamber (EEC) model after 2 weeks of treatment
    Protection of trial subjects
    The trial and site activities were monitored according to the ICH-GCP guidelines considering every aspect of the trial, ensuring that the rights, safety and well-being of patients are protected and consistent with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2012
    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
    Germany: 159
    Worldwide total number of subjects
    159
    EEA total number of subjects
    159
    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)
    157
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Overall, of the 300 patients screened; 159 patients were enrolled in the study and the remaining 141 patients were screen failures.

    Period 1
    Period 1 title
    Overall Trial (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
    		 Test dose 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Test 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    2 sprays each nostril twice daily from Day 1 to Day 15

    Arm title
    		 Test dose 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Test 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    2 sprays each nostril twice daily from Day 1 to Day 15

    Arm title
    		 Test dose 3
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Test 3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    2 sprays each nostril twice daily from Day 1 to Day 15

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    2 sprays each nostril twice daily from Day 1 to Day 15

    Number of subjects in period 1
    		Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Started
    39
    40
    40
    40
    Completed
    39
    36
    38
    39
    Not completed
    0
    4
    2
    1
         Consent withdrawn by subject
    -
    4
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test dose 1
    Reporting group description
    		 -

    Reporting group title
    Test dose 2
    Reporting group description
    		 -

    Reporting group title
    Test dose 3
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Reporting group values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm Total
    Number of subjects
    		 39 40 40 40 159
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39 ( 11.38 ) 37.2 ( 9.50 ) 37.2 ( 11.54 ) 37.9 ( 12.07 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 14 21 18 72
        Male
    		 20 26 19 22 87

    End points

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    End points reporting groups
    Reporting group title
    Test dose 1
    Reporting group description
    		 -

    Reporting group title
    Test dose 2
    Reporting group description
    		 -

    Reporting group title
    Test dose 3
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Primary: Change in total nasal symptom score in a 4-hour environmental challenge with Dactylis glomerate pollen in an environmental exposure chamber

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    End point title
    		 Change in total nasal symptom score in a 4-hour environmental challenge with Dactylis glomerate pollen in an environmental exposure chamber
    End point description
    End point type
    Primary
    End point timeframe
    Day 15 and Day 16
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -2.4852 ( 0.2678 )
    -2.6091 ( 0.2764 )
    -2.7508 ( 0.2680 )
    -1.7166 ( 0.2698 )
        Day 16
    -1.9710 ( 0.2841 )
    -2.0330 ( 0.2975 )
    -2.4925 ( 0.2881 )
    -0.5551 ( 0.2863 )
    Statistical analysis title
    		 change in total nasal symptom score
    Comparison groups
    Test dose 1 v Test dose 2 v Test dose 3 v Placebo arm
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in the amount of nasal secretion in grams in a 4-hour environmental challenge with Dactylis glomerate pollen in an EEC

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    End point title
    		 Change in the amount of nasal secretion in grams in a 4-hour environmental challenge with Dactylis glomerate pollen in an EEC
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15 and Day 16
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -3.6615 ( 0.3943 )
    -3.0711 ( 0.4049 )
    -3.8326 ( 0.3947 )
    -0.7699 ( 0.3955 )
        Day 16
    -2.6152 ( 0.4095 )
    -2.2255 ( 0.4264 )
    -3.0582 ( 0.4155 )
    0.3927 ( 0.4110 )
    Statistical analysis title
    		 Analysis of Nasal Secretion
    Comparison groups
    Test dose 1 v Test dose 3 v Placebo arm v Test dose 2
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Analysis of change in Nasal Congestion

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    End point title
    		 Analysis of change in Nasal Congestion
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15 and Day 16 from baseline
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -0.8386 ( 0.0838 )
    -0.7876 ( 0.0867 )
    -0.8466 ( 0.0838 )
    -0.5186 ( 0.0846 )
        Day 16
    -0.7098 ( 0.0892 )
    -0.6631 ( 0.0937 )
    -0.8125 ( 0.0903 )
    -0.3016 ( 0.0900 )
    Statistical analysis title
    		 Analysis of change in Nasal Congestion
    Comparison groups
    Test dose 1 v Test dose 2 v Test dose 3 v Placebo arm
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0012
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Analysis of Change in Rhinorrhea

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    End point title
    		 Analysis of Change in Rhinorrhea
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15 and Day 16 from baseline
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -0.6078 ( 0.0740 )
    -0.6265 ( 0.0761 )
    -0.6783 ( 0.0741 )
    -0.3762 ( 0.0745 )
        Day 16
    -0.4656 ( 0.0768 )
    -0.3783 ( 0.0801 )
    -0.5572 ( 0.0780 )
    -0.0985 ( 0.0774 )
    Statistical analysis title
    		 Analysis of Change in Rhinorrhea
    Comparison groups
    Test dose 1 v Test dose 2 v Test dose 3 v Placebo arm
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0011
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Analysis of Change in Nasal itching

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    End point title
    		 Analysis of Change in Nasal itching
    End point description
    End point type
    Secondary
    End point timeframe
    DAy 15 and Day 16 from baseline
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -0.6137 ( 0.0794 )
    -0.6275 ( 0.0817 )
    -0.6921 ( 0.0792 )
    -0.4786 ( 0.0794 )
        Day 16
    -0.4816 ( 0.0864 )
    -0.5374 ( 0.0903 )
    -0.6236 ( 0.0874 )
    -0.1624 ( 0.0865 )
    Statistical analysis title
    		 Analysis of Change in Nasal itching
    Comparison groups
    Test dose 1 v Test dose 2 v Test dose 3 v Placebo arm
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0201
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Analysis of Change in Sneezing

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    End point title
    		 Analysis of Change in Sneezing
    End point description
    End point type
    Secondary
    End point timeframe
    DAy 15 and Day 16 from baseline
    End point values
    		 Test dose 1 Test dose 2 Test dose 3 Placebo arm
    Number of subjects analysed
    39
    37
    39
    39
    Units: LSM
    least squares mean (standard error)
        Day 15
    -0.4262 ( 0.0683 )
    -0.5687 ( 0.0701 )
    -0.5327 ( 0.0684 )
    -0.3433 ( 0.0684 )
        Day 16
    -0.3274 ( 0.0798 )
    -0.4380 ( 0.0831 )
    -0.4858 ( 0.0810 )
    -0.0119 ( 0.0800 )
    Statistical analysis title
    		 Analysis of Change in Sneezing
    Comparison groups
    Test dose 1 v Test dose 2 v Test dose 3 v Placebo arm
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0023
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    15 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 -

    Reporting group title
    Arm 2
    Reporting group description
    		 -

    Reporting group title
    Arm 3
    Reporting group description
    		 -

    Reporting group title
    Arm 4
    Reporting group description
    		 -

    Serious adverse events
    		 Arm 1 Arm 2 Arm 3 Arm 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1 Arm 2 Arm 3 Arm 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 39 (43.59%)
    15 / 40 (37.50%)
    20 / 40 (50.00%)
    19 / 40 (47.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 39 (15.38%)
    5 / 40 (12.50%)
    11 / 40 (27.50%)
    10 / 40 (25.00%)
         occurrences all number
    10
    7
    16
    13
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    1
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    2
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    2
    1
    1
    Epistaxis
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Nasal mucosal disorder
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    SINUSITIS
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    0
    1
    NASOPHARYNGITIS
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    2
    0
    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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