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    Summary
    EudraCT Number:2015-005155-27
    Sponsor's Protocol Code Number:KCT09/2015-SeptaNazal-Double
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-06
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovenia - JAZMP
    A.2EudraCT number2015-005155-27
    A.3Full title of the trial
    Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.
    A.4.1Sponsor's protocol code numberKCT09/2015-SeptaNazal-Double
    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 SponsorKrka, d.d., Novo mesto
    B.1.3.4CountrySlovenia
    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 supportKrka, d.d., Novo mesto
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKrka, d.d., Novo mesto
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressDunajska cesta 65
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number0038641589769
    B.5.6E-mailtanja.kohek@krka.biz
    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 Septanazal for adults
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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.3.1Product nameSeptanazal for adults
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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.3.1Product nameXylometazoline chloride
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis
    E.1.1.1Medical condition in easily understood language
    Nasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis
    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 19.0
    E.1.2Level HLT
    E.1.2Classification code 10028736
    E.1.2Term Nasal congestion and inflammations
    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 the double blind, randomized trial is to compare the efficacy of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, on nasal congestion and the healing effect of dexpanthenol in patients after nasal surgery or nasal cavities surgery and patients with acute rhinitis.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients after nasal surgery or nasal cavities surgery (Group 1):
    • Aged 18-60 years
    • Recent nasal surgery or nasal cavities surgery (patients with chronic rinosinusitis with nasal polyps (CRSwNP) and patients with chronic rinosinusitis without nasal polyps (CRSsNP)
    • Can carry out intranasal administration of the investigational medicinal product
    • Signed Informed consent form

    Patients with acute rhinitis (Group 2):
    • Aged 18-60 years
    • Diagnosed with acute rhinitis
    • Can carry out intranasal administration of the investigational medicinal product
    • Signed Informed consent form
    E.4Principal exclusion criteria
    • Hypersensitivity to the active substances or to any of the excipients
    • Dry nasal inflammation (rhinitis sicca)
    • History of transsfenoidal hypophysectomy or other surgical procedures in which the dura mater was exposed
    • Patients who are treated with drugs for local or systemic treatment of influenza, and sympathomimetic agents, which contain a medicament for the treatment for cough and/or cold
    • Pregnancy or breast-feeding
    • Patients with asthma who require treatment with corticosteroids
    • Rhinitis medicamentosa
    • Chronic rhinitis
    • Patients treated with monoamine oxidase inhibitors (MAOIs) or other drugs that may raise blood pressure
    • Patients with increased intraocular pressure, in particular with angle-closure glaucoma
    • Patients with pheochromocytom
    • Nose injury less than 3 months prior the first visit
    • Current treatment with nasal decongestants
    • Respiratory tract infection within 2 weeks prior the first visit (including otitis media), who required treatment with antibiotics
    • Current smoker or ex-smoker less than 6 months prior the first visit
    • Participation in another clinical trial within thirty days prior the first visit
    E.5 End points
    E.5.1Primary end point(s)
    To compare the efficiency of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, on nasal congestion in the two groups of patients:
    • Group 1 - patients after nasal surgery or nasal cavities surgery (CRSwNP and CRSsNP patients)
    • Group 2 - patients diagnosed with acute rhinitis
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 7 days of treatment
    E.5.2Secondary end point(s)
    To compare the efficiency of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2 in the following parameters:
    • swelling of the nasal mucosa
    • dryness of the nasal mucosa
    • burning feeling in the nose
    • crust formation
    • bleeding from nasal mucosa
    • redness of the nasal mucosa and skin at nasal entrance
    • sneezing
    • nasal exudate
    • nasal irritation

    To compare the treatment duration and occurrence of rebound effect between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2.

    To compare the onset of action between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 7 days of treatment
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 270
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-06
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