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    Summary
    EudraCT Number:2008-008734-36
    Sponsor's Protocol Code Number:V00114CP3052A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-02-16
    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 number2008-008734-36
    A.3Full title of the trial
    ESTUDIO DE LA EFICACIA Y SEGURIDAD
    DEL ANTIHISTAMÍNICO V0114CP 2,5 MG
    EN EL TRATAMIENTO DE LA RINITIS ALÉRGICA ESTACIONAL.
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, DE TRES RAMAS Y GRUPOS PARALELOS, QUE INCLUYE UNA RAMA DE PLACEBO Y OTRA
    DE CONTROL ACTIVO (LEVOCETIRIZINA 5 MG)
    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 numberV00114CP3052A
    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-Mequitazina
    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 INNLEVOCETIRIZINA
    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
    Rinitis alérgica
    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
    Demostrar la eficacia en pacientes adultos y adolescentes de un tratamiento de 2 semanas con el antihistamínico V0114CP 2,5 mg frente a placebo en la reducción de síntomas de la rinitis alérgica estacional.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad clínica de V0114CP 2,5 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes que cumplan todos los criterios siguientes serán aptos para su entrada en el estudio:
    - paciente ambulatorio hombre o mujer,
    - no menos de 12 años de edad (o no menos de 18 años según la legislación nacional)
    - que sufra rinitis alérgica estacional por polen de gramíneas y/o hierbas definido por:
    - antecedentes médicos documentados de rinitis estacional durante la estación de polen de gramíneas/hierbas (principalmente de abril a octubre) con síntomas (estornudos y/o prurito palatino y/o rinorrea acuosa y/o bloqueo nasal) durante al menos dos años; si no se dispone de la historia clínica de un paciente nuevo, el diagnostico se evaluará mediante la puntuación para la rinitis alérgica (SFAR),
    - una prueba cutánea (?prick test?) positiva al menos al polen de gramíneas y/o hierbas, en la visita de selección o debidamente documentada en el archivo médico en los últimos 6 meses,
    - con una puntuación de la sintomatología nasal evaluada por el paciente de como mínimo 6 en la inclusión (puntuación máxima: 12),
    - dispuesto y capaz de entender y firmar un formulario de consentimiento informado aprobado, y/o cuyos padres o tutores legales hayan dado su consentimiento por escrito a la participación de su hijo en el estudio,
    - capaz de entender el protocolo y de acudir a las visitas de control, y/o cuyos padres o tutores legales cooperen en cuanto al cumplimiento de las restricciones relacionadas con el estudio,
    - si lo exige la legislación nacional, dado de alta en la seguridad social o en un seguro médico y/o cuyos padres o tutores legales estén dados de alta en la seguridad social o en un seguro médico.

    Para chicas/mujeres con capacidad para concebir:
    - uso de un anticonceptivo eficiente (implantes, inyectable, parche o anticonceptivos orales combinados, algunos dispositivos intrauterinos durante al menos 2 meses antes del estudio y un mes después de la finalización del estudio,
    - prueba de embarazo en orina negativa en la visita de selección
    E.4Principal exclusion criteria
    Los pacientes que cumplan uno de los criterios siguientes no serán aptos 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.
    - Asma que requiera un tratamiento con corticoesteroides (de grado II o superior según la guía de la GINA),
    - Alcoholismo crónico,
    - Antecedentes de agranulocitosis,
    - Galactosemia congénita, síndrome de malabsorción de glucosa o galactosa, o deficiencia de lactasa,
    - Convulsiones,
    - Rinitis iatrogénica,
    - Poliposis nasal o desviación importante del tabique nasal,
    - Antecedentes de cualquier cirugía nasal en los últimos 6 meses,
    - Rinosinusitis aguda o crónica, según la definición epidemiológica de las guías EP3OS,
    - Infección de las vías respiratorias superiores en las últimas 3 semanas.
    - Trastornos psiquiátricos o neurológicos crónicos

    * Criterios relacionados con tratamientos
    - Antecedentes médicos de hipersensibilidad a mequitazina o excipientes farmacológicos,
    - Antecedentes médicos de hipersensibilidad a levocetirizina, a otros derivados piperazínicos o a cualquiera de los excipientes
    - Disfunción renal grave con un aclaramiento de la creatinina de menos de 10 ml/min
    - Problemas hereditarios de intolerancia a la galactosa, malabsorción de la glucosa-galactosa, deficiencia de lactasa
    - Fracaso en un tratamiento previo con levocetirizina,
    - Inmunoterapia anti-alérgica para el polen de gramíneas y/o hierbas
    - con incremento de la exposición a los alérgenos en los últimos 2 años
    - con cualquier dosis en los últimos 6 meses
    - Tratamiento con corticoesteroides de acción prolongada (depot) en los últimos 6 meses,
    - Tratamiento con corticoesteroides orales, nasales, inyectables (intramusculares, intravenosos, intraarticulares, intraespinales) en los últimas 4 semanas,
    - Tratamiento con corticoesteroides tópicos oculares, inhalados, potentes o superpotentes en las últimas 2 semanas,
    - Tratamiento con antileucotrienos en los últimos 7 días,
    - Tratamiento con cromonas o ketotifeno en la última semana,
    - Tratamiento con antihistamínicos H1 en los últimos 7 días, con loratadina en los últimos 10 días,
    - 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 inhibidores de CYP2D6 (fluoxetina, paroxetina, quinidina, tioridazina, clomipramina, haloperidol),
    - Tratamiento con antidepresivos tricíclicos (período de lavado de 4 semanas), IMAO (período de lavado de 4 semanas), fármacos similares a la atropina (período de lavado de 4 semanas).
    Criterios relacionados con la población
    - longitud del intervalo QTc > 450 ms,
    - viaje previsto fuera del área del estudio durante una parte importante del período del estudio,
    - participación en otro ensayo clínico en el mes anterior o durante el estudio,
    - pacientes que, a juicio del investigador, es probable que no cumplan durante el estudio, o padres o tutores legales de pacientes que, a juicio del investigador, es probable que no cumplan durante el estudio,
    - pacientes lingüísticamente o psicológicamente incapaces de entender la información facilitada o de formular el consentimiento informado o que rechacen dar su consentimiento por escrito, o padres o tutores lingüísticamente o psicológicamente incapaces de entender la información facilitada o de dar el consentimiento informado o que rechazan dar su consentimiento por escrito,
    - paciente sujeto a una orden judicial o administrativa o sujeto a custodia o tutela, o padres o tutores legales sujetos a una orden judicial o administrativa o sujetos a custodia o tutela,
    - paciente con quien no se puede contactar por teléfono en una emergencia, o padres o tutores legales con quienes no se puede contactar por teléfono en una emergencia.

    Para chicas/mujeres con capacidad para concebir:
    - embarazo o lactancia o planificación de un embarazo durante el desarrollo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Evolución durante el período de tratamiento de 2 semanas de la puntuación reflexiva de síntomas nasales (NSS) realizada por el paciente (estornudos, rinorrea, prurito nasal, congestión nasal) evaluada diariamente por la noche.
    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 concerned12
    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
    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 state100
    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 Decision2009-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-05-19
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