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    EudraCT Number:2011-002443-10
    Sponsor's Protocol Code Number:2011035
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-14
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-002443-10
    A.3Full title of the trial
    A Randomized, Open-Label, Single-Dose, Parallel Group Study to Evaluate the Utility of Magnetic Resonance Imaging (MRI) in Demonstrating the Nasal Decongestant Efficacy of an Active Control (Vicks® Sinex® Micromist®) Relative to a Sham Control at 8 and 12 Hours Post-Dosing
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the ability of MRI to show changes in the nose after treatment of patients with Vicks® Sinex® Micromist®
    A.4.1Sponsor's protocol code number2011035
    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 SponsorProcter & Gamble Technical Centres Ltd., UK
    B.1.3.4CountryUnited Kingdom
    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 supportProctor & Gamble (Health and Beauty Care) Ltd.,
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchool of Physics and Astronomy
    B.5.2Functional name of contact pointPenny Gowland
    B.5.3 Address:
    B.5.3.1Street AddressSir Peter Mansfield Magnetic Resonance Centre,
    B.5.3.2Town/ cityUniversity Park, Nottingham
    B.5.3.3Post codeNG7 2RD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number(+44) (0) 115 95 1475
    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. name Vicks® Sinex Micromist®
    D. of the Marketing Authorisation holderProcter & Gamble (Health & Beauty Care) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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, solution
    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.3.9.1CAS number 2315-02-8
    D.3.9.4EV Substance CodeSUB03589MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 due to the common cold or hay fever
    E.1.1.1Medical condition in easily understood language
    stuffy or blocked nose due to the common cold or 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 13.1
    E.1.2Level PT
    E.1.2Classification code 10028735
    E.1.2Term Nasal congestion
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this method development study is to evaluate the utility of MRI in demonstrating the nasal decongestant efficacy of an active control (Vicks® Sinex® Micromist®) at 8 and 12 hours after dosing relative to a sham control.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be considered for admission to this study:

    a) have provided written informed consent;
    b) are generally healthy by report and review of medication/medical history;
    c) are at least 18 years of age and not older than 65 years of age, inclusive, at screening;
    d) report suffering from nasal congestion due to common cold or hay fever;
    e) rate the severity of their nasal congestion as either a 2=Moderate (definite awareness of sign/symptom that is bothersome but tolerable) or 3=Severe (sign/symptom that is hard to tolerate) on the Nasal Congestion Severity Scale (Section;
    f) if female and of child-bearing potential, have practiced abstinence or used an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 3 months before being enrolled in the study;
    g) have a body mass index (BMI) ≥18.5 but ≤ 32 kg/m2;
    h) be willing to refrain from exercise, alcohol, hot spicy food, hot drinks and any medication, homeopathic, home remedy, dietary supplement, herbal remedy, and saline spray listed in the exclusion criteria throughout the study;
    i) be willing and able to comply with MRI instructions (Appendix 3);
    j) be willing to refrain from smoking, eating and drinking during Visit 1 and starting 1 hour prior to and during Visit 2 (room temperature water will be permitted ad lib while at the site); and,
    k) have a peak nasal inspiratory flow of < 105 L/min (Section
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if any of the following apply:

    a) are female and have a positive urine pregnancy test at screening or report they are pregnant, trying to become pregnant, or lactating;
    b) have a body temperature greater than 38.1º Celsius;
    c) have blood pressure exceeding either 138mm Hg systolic or 88mm Hg diastolic (an average of three readings after sitting for 5 minutes);
    d) have a history of rhinitis medicamentosa or frequent nose bleeds;
    e) have a dependence upon nasal, oral, or ocular decongestants, that, in the opinion of the Investigator would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
    f) have a clinically significant nasal abnormality (e.g., deviated septum, ulcer, septal perforation, or polyp) discovered during the nasal examination;
    g) have a history of cardiovascular disease, thyroid disease, diabetes mellitus, hypertension, prostatic hypertrophy, hepatic or renal disease;
    h) have a history of clinically significant pulmonary, autoimmune, psychiatric, metabolic, neurologic, hematologic/oncologic (except for treated basal cell carcinoma with a documented 6-month remission), metabolic, endocrine or gastrointestinal disease;
    i) have an acute illness (other than cold and hay fever) during the two weeks preceding the study or have a condition or are taking a medication that the Investigator believes would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
    j) have a history of allergy or hypersensitivity or abnormal reaction to Vicks® Sinex® Micromist® or the following ingredients: oxymetazoline hydrochloride, levomenthol, sodium citrate dihydrate, tyloxapol, citric acid anhydrous, chlorhexidine gluconate solution, benzalkonium chloride solution, camphor, disodium edetate dihydrate, eucalyptol, sodium hydroxide and purified water
    k) have a history of alcohol or drug abuse within the past 2 years;
    l) have used intranasal or systemic corticosteroids or leukotriene antagonists/synthase inhibitors within the past 30 days;
    m) have used inhaled, topical, or oral nedocromil or intranasal cromolyn, tricyclic antidepressant medications, or MAO inhibitors within the past 14 days;
    n) have used intranasal or systemic decongestants or intranasal or systemic antihistamines within the past 3 days;
    o) are taking bromocriptine, antibiotics or antiviral medications;
    p) have consumed alcohol, nasal, throat or lung inhalants, or any products (e.g., medications, homeopathics, home remedies, dietary supplements, herbal remedies, saline sprays) for common cold or hay fever within the past 12 hours;
    q) have exercised within the past 6 hours;
    r) are currently enrolled in another clinical trial, or have received any other investigational drug within the past 3 months;
    s) do not meet all the criteria in the MR Safety Screening Questionnaire (Appendix 2)
    t) are unable to follow MRI instructions (Appendix 3);
    u) have demonstrated an unwillingness to comply with protocol requirements (e.g., uncooperative attitude, inability to return for all scans, history of medical non-compliance) and/or poor likelihood of completing the study.
    E.5 End points
    E.5.1Primary end point(s)
    As Above
    E.5.1.1Timepoint(s) of evaluation of this end point
    8hr, 12hr
    E.5.2Secondary end point(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    efficacy in reduction of nasal airway resistance (NAR) out to 12 hours
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    Sham treatment with empty Vicks® Sinex® Micromist® bottle
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Subjects will be compensated for their participation in the study and discharged from the study centre.
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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)
    Not Applicable
    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 Decision2011-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-21
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