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    Summary
    EudraCT Number:2013-002977-23
    Sponsor's Protocol Code Number:Tav02-13
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-002977-23
    A.3Full title of the trial
    Double-blind, randomised, placebo-controlled study evaluating the efficacy and Safety of Tavipec® capsules in acute Rhinosinusitis
    A prospective, multi-centre, parallel group, interventional clinical phase IV study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Tavipec versus Placebo in patients with acute Rhinosinusitis
    A.4.1Sponsor's protocol code numberTav02-13
    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 SponsorMontavit Ges.m.b.H.
    B.1.3.4CountryAustria
    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 supportMontavit Ges.m.b.H.
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMontavit
    B.5.2Functional name of contact pointclinical trial manager
    B.5.3 Address:
    B.5.3.1Street AddressSalzbergstraße 96
    B.5.3.2Town/ cityABSAM
    B.5.3.4CountryAustria
    B.5.4Telephone number00430522357926234
    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 Tavipec®
    D.2.1.1.2Name of the Marketing Authorisation holderMontavit
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nametavipec
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNspicae
    D.3.9.1CAS number 8016-87-2
    D.3.9.3Other descriptive nameOLEUM SPICAE
    D.3.9.4EV Substance CodeSUB14687MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,15 g/capsule
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Rhinosinusitis
    E.1.1.1Medical condition in easily understood language
    acute Rhinosinusitis
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose
    E.2.2Secondary objectives of the trial
    - - Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose
    - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose
    - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose
    - % of patients with improvement of health-related QOL score as revealed by SNOT 22 by at least ten score points
    - Global impact of disease on QOL as assessed by patient
    - Adverse event rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male and female outpatients aged ≥ 18 - 75 years
    2. Acute rhinosinusitis complying with following symptoms:
    o Rhinorrhea
    o Postnasal drip
    o Nasal congestion/stuffiness
    o Sinus headache
    o Facial pain
    o Reduction/loss of smell (hyposmie)
    3. Sublingual temperature < 38.3°C, no dental involvement, impairment of general conditions.
    4. Major Symptom Score (MSS) (> 5 but < 12)
    5. ARS symptoms at enrolment do not exceed 3 days
    6. Informed consent and willingness to comply with the protocol
    E.4Principal exclusion criteria
    - Signs or symptoms suggestive of acute bacterial rhinosinusitis (sublingual temperature >38.3°C, persistent severe unilateral facial or tooth pain, facial swelling, severe frontal or retroorbital pain radiating to the occiput) or of extrasinus manifestations, such as orbital cellulitis, dental or facial abscess, cavernous vein thrombosis
    - Chronic recurrent rhinosinusitis with more than 4 episodes of acute rhinosinusitis per year and no complete resolution in-between
    - Immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa
    - Known or suspected hypersensitivity to the active substance and/or to any of the excipients
    - Need for antibiotic treatment in patients at high risk of serious complications because of pre-existing comorbidity, including significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, human immunodeficiency virus infection, malignancy other than squamous or basal cell carcinoma of the skin
    - Antibiotic therapy (local or systemic) at any time during the preceding four weeks
    - Need for application of concomitant local medications including antibiotics, corticosteroids, antihistaminic agents
    - Immunosuppressive therapy and/or systemic corticosteroids
    - Systemic antihistaminic agents
    - Radiation therapy or chemotherapy within the previous 12 months
    - Pregnancy or lactating women
    - History of alcohol or drug abuse likely to lead to uncooperative behavior
    - History of psychiatric and/or neurological illness likely to lead to uncooperative behavior
    - Participation in another clinical trial within 1 month
    - Patients using medication for treatment of common cold like symptoms (excluding nasal douche)
    E.5 End points
    E.5.1Primary end point(s)
    Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 4 days of full medication dose
    E.5.2Secondary end point(s)
    - - Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose
    - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose
    - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose
    - % of patients with improvement of health-related QOL score as revealed by SNOT 22 by at least ten score points
    - Global impact of disease on QOL as assessed by patient
    - Adverse event rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline; after 4 and 7 days of full medication dose
    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 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) No
    E.8.2.2Placebo Yes
    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.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    Final assessment (day 7 or at any time in case of discontinuation of treatment)
    - Reason for discontinuation of therapy
    - Assessment of failures
    - Assessment of compliance
    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 months8
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state280
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-24
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