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    Summary
    EudraCT Number:2007-003572-19
    Sponsor's Protocol Code Number:V00114 CP 302 2A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-003572-19
    A.3Full title of the trial
    EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG
    IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)
    (Estudio de la eficacia y seguridad del antihistamínico V0114CP 2,5 mg en el tratamiento de la rinitis alérgica perenne. Estudio aleatorizado, doble ciego, en tres grupos paralelos, incluyendo un grupo placebo y un grupo control activo (levocetirizina 5 mg) )
    A.4.1Sponsor's protocol code numberV00114 CP 302 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 Médicament
    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 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.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
    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*
    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
    La indicación prevista para este producto en desarrollo es el tratamiento de la rinitis alérgica perenne.
    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
    El objetivo principal es demostrar la eficacia de un tratamiento de 6 semanas con el antihistamínico V0114CP 2,5 mg frente a placebo en la reducción de síntomas de la rinitis alérgica perenne..
    E.2.2Secondary objectives of the trial
    - evaluar la valoración global,
    - evaluar la seguridad clínica y biológica de V0114CP 2,5 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes que cumplen todos los criterios siguientes serán elegibles para su entrada en el estudio:
    - pacientes ambulatorios, varones y mujeres, mayores de 18 años de edad,
    - sufrir rinitis alérgica perenne (a los ácaros del polvo, escamas de animales, cucarachas) definida por:
    - antecedentes médicos documentados de rinitis perenne con síntomas (estornudos y/o picor nasal y/o bloqueo nasal) durante al menos dos años; si no se dispone de los registros médicos de un paciente nuevo, el diagnostico clínico se evaluará mediante la puntuación para la rinitis alérgica (SFAR),
    NB: Los pacientes con episodio(s) de rinitis alérgica estacional sintomática son elegibles si el periodo 1 del estudio (primeras 6 semanas) se realiza fuera del(los) periodo(s) en los que existen los alérgenos estacionales correspondientes (p. ej.: castaño, aliso gris, ciprés, abedul plateado, mimosa, fresno blanco, parietaria officinalis).
    - prueba de punción cutánea (prick test) positiva y/o positividad para IgE específica (clase ≥ 3 o equivalente) de los alérgenos correspondientes (ácaros del polvo, escamas de animales, cucarachas) debidamente documentada en el archivo médico en los últimos 12 meses.
    - con una puntuación instantánea de síntomas nasales matutinos ≥ 6 durante al menos 4 días durante los 7 días previos a la inclusión (puntuación máxima: 12),
    - en caso de asma bronquial asociada, sólo se permitirá asma intermitente leve, que no requiera tratamiento con corticoesteroides,
    - estar dispuesto y entender y firmar un formulario de consentimiento informado aprobado,
    - capaz de entender el protocolo y asistir a las visitas de control,
    Para mujeres con capacidad para concebir:
    - uso de un método anticonceptivo (anticonceptivo oral, dispositivo intrauterino, ligadura de trompas),
    - prueba de embarazo en orina negativa.
    E.4Principal exclusion criteria
    Los pacientes que cumplan uno de los criterios siguientes no serán elegibles para su entrada en el estudio:
    * Criterios relacionados con enfermedades
    - Cualquier enfermedad grave cardiovascular, renal, hepática, gastrointestinal, endocrina, hematológica, neuropsiquiátrica que, en opinión del investigador, no sea compatible con la participación en el estudio.
    - Cualquier enfermedad aguda o crónica que, en opinión del investigador, no permita la participación en el estudio.
    - Alcoholismo crónico,
    - Antecedentes de agranulocitosis,
    - Galactosemia congénita, síndrome de malabsorción de glucosa o galactosa, o deficiencia de lactasa,
    - Convulsiones,
    - Obstrucción nasal grave (puntuación = 3),
    - Rinitis yatrógena,
    - Poliposis nasal o desviación importante del tabique nasal,
    - Antecedentes de cirugía nasal,
    - Rinosinusitis aguda o crónica, definido según la guía EP 3OS,
    - Infección de las vías respiratorias superiores en las últimas 3 semanas.

    * Criterios relacionados con tratamientos
    - Antecedentes médicos de hipersensibilidad a mequitazina o excipientes farmacológicos,
    - Desensibilización específica a alérgenos perennes finalizada en los últimos 6 meses, cualquiera que sea el problema,
    - Tratamiento con corticoesteroides de acción prolongada (depot) en los últimos 6 meses,
    - Tratamiento con corticoesteroides orales, intramusculares o intravenosos en las últimas 8 semanas,
    - Tratamiento con corticoesteroides nasales u oculares en las últimas 4 semanas,
    - Tratamiento con corticoesteroides inhalados en los últimos 4 meses,
    - Corticosteroides tópicos potentes y/o superpotentes en las últimas 4 semanas,
    - Tratamiento con antileucotrienos en los últimos 7 días,
    - Tratamiento con cromona o ketotifeno en las últimas 2 semanas,
    - Tratamiento con antihistamínicos en los últimos 7 días, con loratadina en los últimos 10,
    - Tratamiento con AINE (que no sean del grupo de los oxicams) en los últimos 3 días,
    - Tratamiento con fármacos del grupo de los oxicams en los últimos 7 días,
    - Tratamiento regular con descongestionantes nasales u orales en los últimos 7 días,
    - Tratamiento con antidepresivos tricíclicos (periodo de lavado de 4 semanas), IMAO (periodo de lavado de 4 semanas), fármacos similares a la atropina (periodo de lavado de 4 semanas).

    * Criterios relacionados con la población
    - cumplimiento insatisfactorio para rellenar el diario durante el periodo de selección, según el criterio del investigador;
    - participación en otro ensayo clínico en el mes anterior o durante el estudio,
    - paciente que, según el criterio del investigador, es probable que no cumpla durante el estudio,
    - paciente que ha perdido su libertad por sentencia administrativa o legal, o que está en custodia legal,
    - sujeto con el que no se puede contactar en caso de urgencia.

    Para mujeres con capacidad para concebir:
    - embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    evolución durante el periodo de tratamiento de 6 semanas de la puntuación instantánea de síntomas nasales (NSS) realizada por el paciente (estornudos, rinorrea, picor nasal, bloqueo nasal) evaluada diariamente por la mañana.
    - Análisis de la covarianza en el cambio medio diario de la NSS en 6 meses, con la NSS basal como covariable (análisis principal) en la población FAS.
    - El mismo análisis en la población PP.
    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.8.4.1Number of sites anticipated in Member State concerned100
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio será en la fecha de la última visita (visita 10) del último paciente que participe en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years2
    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 900
    F.4.2.2In the whole clinical trial 1080
    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 Decision2008-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-07
    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
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