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    Clinical Trial Results:
    Safety and Pharmacokinetics of PATANASE® in Pediatric Patients 2 to < 6 Years of Age Who Have a History of Allergic Rhinitis

    Summary
    EudraCT number
    		 2017-003970-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Dec 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2018
    First version publication date
    25 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-07-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research Ltd
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733391, dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733391, dennis.wong@novartis.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Dec 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess the safety and pharmacokinetic of Olopatadine Hydrochloride Nasal Spray 0.6% administered twice daily in pediatric patients 2 to < 6 years of age.
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2008
    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 States: 132
    Worldwide total number of subjects
    132
    EEA total number of subjects
    0
    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)
    132
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 9 study centers located in the US.

    Pre-assignment
    Screening details
    		 This reporting group includes all randomized and treated subjects (132).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Olo 0.6% 1 Spray
    Arm description
    		 Olopatadine Hydrochloride Nasal Spray 0.6%, 1 spray in each nostril twice daily (BID) for 14 days, 1 single dose on Day 15
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olopatadine Hydrochloride Nasal Spray 0.6%
    Investigational medicinal product code
    Other name
    PATANASE®
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray in each nostril BID for 14 days, 1 single dose on the 15th day

    Arm title
    		 Veh 1 Spray
    Arm description
    		 Olopatadine Hydrochloride Nasal Spray Vehicle, 1 spray in each nostril BID for 15 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Olopatadine Hydrochloride Nasal Spray Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray in each nostril BID for 15 days

    Number of subjects in period 1
    		Olo 0.6% 1 Spray Veh 1 Spray
    Started
    66
    66
    Completed
    63
    63
    Not completed
    3
    3
         Reason not given
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray 0.6%, 1 spray in each nostril twice daily (BID) for 14 days, 1 single dose on Day 15

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray Vehicle, 1 spray in each nostril BID for 15 days

    Reporting group values
    		 Olo 0.6% 1 Spray Veh 1 Spray Total
    Number of subjects
    		 66 66 132
    Age categorical
    This analysis population includes all enrolled subjects who received at least one dose of study medication (Safety Analysis Set)
    Units: Subjects
        2 to <4 years
    		 37 34 71
        4 to <6 years
    		 29 32 61
    Gender categorical
    Units: Subjects
        Female
    		 28 36 64
        Male
    		 38 30 68

    End points

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    End points reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray 0.6%, 1 spray in each nostril twice daily (BID) for 14 days, 1 single dose on Day 15

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray Vehicle, 1 spray in each nostril BID for 15 days

    Primary: Number of Serious Adverse Events (SAEs)

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    End point title
    		 Number of Serious Adverse Events (SAEs) [1]
    End point description
    Adverse events were defined as any change (expected or unexpected) in a subject’s nasal and/or medical health that occurred after initiation of study treatment.
    End point type
    Primary
    End point timeframe
    Up through Day 15
    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: No formal statistical analysis was planned or conducted for this primary endpoint. Descriptive tables for adverse events were provided.
    End point values
    		 Olo 0.6% 1 Spray Veh 1 Spray
    Number of subjects analysed
    66
    66
    Units: number
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum plasma concentration (Cmax)

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    End point title
    		 Maximum plasma concentration (Cmax) [2]
    End point description
    Plasma concentrations of olopatadine and its active metabolites [N-desmethyl olopatadine (M1), N-didesmethyl olopatadine (M2), and olopatadine N-oxide (M3)] were measured, and pharmacokinetic (PK) parameters for olopatadine and M1, M2, and M3 were estimated using a population PK model. There were no measurable plasma concentrations for M2. Mean systemic exposure parameters were based on post hoc individual parameter estimates.
    End point type
    Secondary
    End point timeframe
    Up through Day 15
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects administered experimental drug were analyzed. Descriptive tables for pharmacokinetic parameters were provided.
    End point values
    		 Olo 0.6% 1 Spray
    Number of subjects analysed
    66
    Units: ng/mL
    arithmetic mean (standard deviation)
        Olopatadine
    13.4 ± 4.60
        M1
    0.219 ± 0.078
        M3
    0.34 ± 0.152
    No statistical analyses for this end point

    Secondary: Time to attain Cmax from time of last dose (Tmax)

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    End point title
    		 Time to attain Cmax from time of last dose (Tmax) [3]
    End point description
    Plasma concentrations of olopatadine and its active metabolites, M1, M2, and M3 were measured, and PK parameters were estimated using a population PK model. There were no measurable plasma concentrations for M2. Mean systemic exposure parameters were based on post hoc individual parameter estimates.
    End point type
    Secondary
    End point timeframe
    Up to Day 15
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects administered experimental drug were analyzed. Descriptive tables for pharmacokinetic parameters were provided.
    End point values
    		 Olo 0.6% 1 Spray
    Number of subjects analysed
    66
    Units: hours
    arithmetic mean (standard deviation)
        Olopatadine
    0.918 ± 0.293
        M1
    2.51 ± 0.245
        M3
    1.50 ± 0.224
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration - time curve (AUC0-12)

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    End point title
    		 Area under the plasma concentration - time curve (AUC0-12) [4]
    End point description
    Plasma concentrations of olopatadine and its active metabolites, M1, M2, and M3 were measured, and PK parameters were estimated using a population PK model. There were no measurable plasma concentrations for M2. Mean systemic exposure parameters were based on post hoc individual parameter estimates. AUC0-12 at steady state was determined as the ratio of dose to clearance of the analyte.
    End point type
    Secondary
    End point timeframe
    Up to Day 15
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects administered experimental drug were analyzed. Descriptive tables for pharmacokinetic parameters were provided.
    End point values
    		 Olo 0.6% 1 Spray
    Number of subjects analysed
    66
    Units: ng*h/mL
    arithmetic mean (standard deviation)
        Olopatadine
    75.0 ± 26.4
        M1
    1.56 ± 0.54
        M3
    2.03 ± 0.917
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Only total subjects affected by non-serious AEs that occur at >5% are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray 0.6%, 1 spray in each nostril twice daily (BID) for 14 days, 1 single dose on the 15th day

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine Hydrochloride Nasal Spray Vehicle, 1 spray in each nostril BID for 15 days

    Serious adverse events
    		 Olo 0.6% 1 Spray Veh 1 Spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olo 0.6% 1 Spray Veh 1 Spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 66 (22.73%)
    14 / 66 (21.21%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 66 (6.06%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 66 (3.03%)
    6 / 66 (9.09%)
         occurrences all number
    2
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 66 (9.09%)
    0 / 66 (0.00%)
         occurrences all number
    6
    0
    Vomiting
         subjects affected / exposed
    3 / 66 (4.55%)
    4 / 66 (6.06%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 66 (9.09%)
    7 / 66 (10.61%)
         occurrences all number
    6
    7
    Epistaxis
         subjects affected / exposed
    4 / 66 (6.06%)
    1 / 66 (1.52%)
         occurrences all number
    4
    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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