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    Summary
    EudraCT Number:2006-006947-30
    Sponsor's Protocol Code Number:V00114 CP 301 2A
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-006947-30
    A.3Full title of the trial
    EFFICACY STUDY OF THE ANTIHISTAMINE V0114 CP 2.5MG TABLET
    IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS.
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    A.4.1Sponsor's protocol code numberV00114 CP 301 2A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 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.3.2Product code V0114 CP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV0114
    D.3.9.3Other descriptive nameL-MEQUITAZINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    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
    ALLERGIC RHINITIS

    prospective, multicentric, international, randomised, double-blind trial in two parallel groups: V0114CP 2.5 mg tablet versus placebo.

    This study is planned to assess the efficacy of V0114CP 2.5 mg in symptoms relief during seasonal allergic rhinitis.
    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
    Objectives :
    Primary :
    - to demonstrate the efficacy of a 2-week treatment by the antihistamine V0114CP 2.5 mg in reducing symptoms during seasonal allergic rhinitis.
    E.2.2Secondary objectives of the trial
    Objectives :
    Secondary:
    - to evaluate the percentage of success to treatment
    - to evaluate the onset of action
    - to evaluate the clinical global improvement
    - to evaluate the systemic tolerance of V0114CP 2.5 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    Patients with all the following criteria will eligible for enrolment:
    - over 18 year-old male or female ambulatory patient,
    - suffering from a seasonal allergic rhinitis to grass pollen grain defined by :
    - a recorded medical history of seasonal rhinitis during the grass pollen season (May to July) with symptoms (sneezing and/or palate itching and/or aqueous rhinorrhea and/or nasal blockade) for at least two years; if, for a new patient, the medical history has never been recorded, the diagnosis will be assessed by the score for allergic rhinitis (SFAR),
    - a positive prick test to grass pollen grains, and/or positive specific IgE (class ³3 or equivalent) duly documented in the medical file within the past 6 months,
    - with a nasal symptomatology score equal or superior to 6 at inclusion (maximal score: 12),

    - in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring systemic corticosteroids or whose use of inhaled corticosteroids has not been changed within the last month,
    - willing and able to understand and sign an approved Informed Consent Form,
    - able to understand the protocol and to attend the control visits,
    - if required by national regulation, registered with a social security or health insurance system.
    For women of child bearing potential:
    - use of an contraceptive method (oral contraceptive, intra-uterine device, tubal ligature, double barrier method: spermicide gel + condom).
    E.4Principal exclusion criteria
    Exclusion criteria:
    Criteria related to pathologies
    - Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that will not be compatible with the participation to the study in the opinion of the investigator,
    - Any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator,
    - Chronic alcoholism,
    - History of agranulocytosis,
    - Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency,
    - Seizure,
    - Iatrogenic rhinitis,
    - Nasal polyposis or severe symptomatic deviation of the nasal septum,
    - History of nasal surgery in the previous 6 months,
    - Documented evidence of acute or significant chronic sinusitis,
    - Upper respiratory tract infection within the last 3 weeks.

    Criteria related to treatments
    - Medical history of hypersensitivity to mequitazine or drug excipients,
    - Specific desensitization to grass pollens finished within the last 12 months whatever the issue,
    - Corticosteroid treatment within the last 6 months (delayed steroids) or within the last 4 weeks (oral, intravenous, nasal, potent or super-potent cutaneous),
    - Treatment by antileukotriene within the last 2 weeks,
    - Treatment by local or oral cromone or ketotifen within the last 2 weeks,
    - Treatment by local or oral antihistamine within the last 2 weeks,
    - Treatment by NSAIDs (other than oxicams) within the last three days,
    - Treatment by oxicams within the last 8 days,
    - Treatment by nasal or systemic decongestive drug: wash-out of 4 weeks if regular use, of 72 hours if intermittent use,
    - Treatment by tricyclic antidepressants, MAO inhibitors, atropine-like drugs within the last month.

    * Criteria related to the population
    - Planned travel outside the study area for a substantial portion of the study period,
    - Participation to another clinical trial in the previous month or during the study,
    - Patient who, in the judgement of the investigator is not likely to be compliant during the study,
    - Patient who has forfeited his/her freedom by administrative or legal award, or who is under guardianship,
    - Subject who cannot be contacted in case of emergency.
    For women:
    - Pregnancy or breast feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Primary criterion :
    evolution over the 14 days treatment period of the reflective (12 hours) patient-rated nasal symptom score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening.

    The primary efficacy criterion is the change from baseline of the reflective patient-rated nasal symptom score (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening, recording by the optic pens, over the 2-week treatment period.

    Primary analysis

    The primary efficacy analysis will use a likelihood-based Mixed-effects Model for Repeated Measures (MMRM) on the patient-rated reflective nasal symptom score change from baseline to week 2 (D14) and will be performed on the FAS with observed case (OC) approach. The model will include Treatment, Centre and Visits as main effects, baseline reflective NSS score as covariate.
    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) 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.8.3 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.8.5.1Number of sites anticipated in the EEA90
    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 Information not present in EudraCT
    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
    LAST VISIT OF THE LAST SUBJECT UNDERGOING THE TRIAL
    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
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 460
    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 Decision2007-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-25
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