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    Summary
    EudraCT Number:2008-008734-36
    Sponsor's Protocol Code Number:V00114CP305 2A
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2008-008734-36
    A.3Full title of the trial
    EFFICACY AND SAFETY STUDY
    OF THE ANTIHISTAMINE V0114CP 2.5MG
    IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS.
    RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY
    INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG).
    A.4.1Sponsor's protocol code numberV00114CP305 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.3.1Product nameV0114
    D.3.2Product code V0114CP02A
    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 codeV0114CP02A
    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.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 Yes
    D.2.1.1.1Trade name XYZALL
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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.3.8INN - Proposed INNLEVOCETIRIZINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule, hard
    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
    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
    to demonstrate the efficacy in adult and adolescent patients of a 2-week treatment by the antihistamine V0114CP 2.5 mg versus placebo in reducing symptoms during seasonal allergic rhinitis.
    E.2.2Secondary objectives of the trial
    to evaluate the clinical safety of V0114CP 2.5 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with all the following criteria will be eligible for enrolment:
    - male or female ambulatory patient,
    - no less than 12 year-old (or no less than 18year-old according to National Legislation)
    - suffering from a seasonal allergic rhinitis to grass and or weed pollen grain defined by :
    -- a documented medical history of seasonal rhinitis during the grass/weed pollen season (mainly April to October) 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 documented, the diagnosis will be assessed by the score for allergic rhinitis (SFAR),
    -- a positive skin prick test at least to grass and or weed pollen grains, at selection visit or duly documented in the medical file within the last 6 months,
    -- with a nasal symptomatology score rated by the patient equal or superior to 6 at inclusion (maximal score: 12),
    - willing and able to understand and sign an approved Informed Consent Form, and/or whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study,
    - able to understand the protocol and to attend the control visits, and/or whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints,
    - if required by national regulation, registered with a social security or health insurance system and/or whose parent(s) or guardian(s) is(are) registered with a social security or health insurance system.
    For girls/women of childbearing potential:
    - use of an efficient contraceptive (implants, injectable, patch or combined oral contraceptives, some intra-uterine devices for at least 2 months before the study and one month after the end of the study,
    - negative urine pregnancy test at selection visit.
    E.4Principal exclusion criteria
    Patients with one of the following criteria will not be eligible for enrolment:
    * Criteria related to pathologies:
    - Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuropsychiatric 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,
    - Asthma requiring a corticosteroid treatment (GINA II and higher),
    - Chronic alcoholism,
    - History of agranulocytosis,
    - Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency,
    - Seizure,
    - Iatrogenic rhinitis,
    - Nasal polyposis or severe deviation of the nasal septum,
    - History of any nasal surgery within the last 6 months,
    - Acute or chronic rhinosinusitis, as stated by the epidemiological definition of the EP3OS guideline,
    - Upper respiratory tract infection within the last 3 weeks.
    - Chronic neurologic or psychiatric diseases

    *Criteria related to treatments:
    - Medical history of hypersensitivity to mequitazine or drug excipients,
    - Medical history of hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients
    - Severe renal impairment at less than 10 ml/min creatinine clearance
    - Hereditary problems of galactose intolerance, glucose-galactose malabsorption, lactase deficiency
    - Failure to a previous treatment with levocetirizine,
    - Anti-allergy immunotherapy to grass and or weed pollens
    -- with increase of allergen challenges in the previous 2 years
    -- at any dose in the previous 6 months
    - Depot corticosteroid treatment within the last 6 months,
    - Oral, nasal, injectable (intramuscular, intravenous, intra-articular, intraspinal) corticosteroid treatment within the last 4 weeks,
    - Ocular, inhaled, potent or superpotent topical corticosteroid treatment within the last 2 weeks,
    - Treatment by antileukotriene within the 7 days,
    - Treatment by cromone or ketotifen within the last 1 week,
    - Treatment by H1 antihistamine within the last 7 days, by loratadine within the last 10 days,
    - Treatment by NSAIDs (other than oxicams) within the last 3 days,
    - Treatment by oxicams within the last 7 days,
    - Regular treatment by nasal or oral decongestive drug within the last 7 days,
    - Treatment by CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine, thioridazine, clomipramine, haloperidol),
    - Treatment by tricyclic antidepressants (wash-out 4 weeks), MAO inhibitors (wash-out 4 weeks), atropine-like drugs (wash-out 4 weeks).
    * Criteria related to the population:
    - length of QTc interval > 450 ms,
    - 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, or parent(s) or guardian(s) subject who, in the judgement of the investigator is/are not likely to be compliant during the study,
    - patient linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or to give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing,
    - patient subject to an administrative or court order or subject to guardianship or wardship or parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship,
    - patient who cannot be contacted by telephone in an emergency, or parent(s) or guardian(s) who cannot be contacted by telephone in an emergency.
    For girls/women of childbearing potential:
    - pregnancy or breast feeding or planning a pregnancy during the course of the study.
    E.5 End points
    E.5.1Primary end point(s)
    evolution over the 2-week treatment period of the patient-rated reflective
    nasal symptom score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    The 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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 900
    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 Decision2009-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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