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    Summary
    EudraCT Number:2017-003970-16
    Sponsor's Protocol Code Number:C-07-02
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-11-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-003970-16
    A.3Full title of the trial
    Safety and Pharmacokinetics of PATANASE in Paediatric Patients 2 to < 6 Years of Age with a history of allergic rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Pharmacokinetics of PATANASE in Paediatric Patients 2 to < 6 Years of Age with a history of allergic rhinitis
    A.4.1Sponsor's protocol code numberC-07-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00794144
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Research Ltd
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlcon Research Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharmaceuticals
    B.5.2Functional name of contact pointOphthalmology Unit
    B.5.3 Address:
    B.5.3.1Street AddressPark View, Riverside Way, Watchmoor Park
    B.5.3.2Town/ cityCamberley Surrey
    B.5.3.3Post codeGU15 3YL
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 44 0127666733391
    B.5.6E-mailDennis.wong@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Patanase
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolopatadine hydrochloride
    D.3.9.1CAS number 140462-76-6
    D.3.9.3Other descriptive nameOLOPATADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03509MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    Hay fever
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to describe the safety and pharmacokinetic of Olopatadine Hydrochloride Nasal Spray 0.6% administered twice daily in pediatric patients 2 to < 6 years of age.
    E.2.2Secondary objectives of the trial
    The purpose of this study is to describe the safety and pharmacokinetic of Olopatadine Hydrochloride Nasal Spray 0.6% administered twice daily in pediatric patients 2 to < 6 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 2 years of age and less than 6 years of age on Day 1;
    2. Parent/legal guardian was willing and able to give written informed consent and
    a. provided this consent for the study;
    3. Positive case history of allergic rhinitis symptoms and at least one documented positive skin test within the 5 years prior to Day 1;
    4. Willing and able to make required study visits and able to follow instructions;
    5. Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations at Screening and prior to administration of test article at the Day 1 Visit;
    6. Other protocol-specified inclusion criteria may apply.
    E.4Principal exclusion criteria
    1. Chronic or intermittent use of any prescription or over-the-counter nasal spray during the study period;
    2. Use of any form of olopatadine (e.g., PATANOL®, PATADAY™, PATANASE®) within 7 days of Day 1;
    3. Currently or recent (within 14 days) use of any drugs/drug classes or combinations thereof that may prolong the QT interval;
    4. History, diagnosis, or evidence of infection, syndrome, disease, abnormality, or malfunction that may interfere with the investigation, evaluation of study medication, or results of the study, as specified in the protocol;
    5. Hypersensitivity to olopatadine, benzalkonium chloride, or any component of the test articles;
    6. Other protocol-specified exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants With Anatomic Nasal Exam Abnormalities [ Time Frame: Day 1
    (Baseline) to Exit ]
    The appearance in a participant of any of the following from Baseline: anatomic
    abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up through Day 15
    E.5.2Secondary end point(s)
    Maximum plasma concentration (Cmax)

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

    Area under the plasma concentration - time curve (AUC0-12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up through Day 15
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and Pharmacokinetics
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 132
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 132
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children under the age of 18
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 132
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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