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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-004094-93
    Sponsor's Protocol Code Number:PAFCUTIII
    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:2012-02-21
    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 number2011-004094-93
    A.3Full title of the trial
    Double-blind, three-way cross-over, placebo controlled study to assess the efficacy, safety and mechanisms of treatment with rupatadine 20 and 40 mg in cold contact urticaria (CCU)
    Función de la liberación de la Histamina y del factor de activación plaquetario (PAF) en la inflamación cutánea después de la provocación con agua fría en pacientes con urticaria por contacto al frío (CCU) tratados con rupatadina 20 y 40 mg. Estudio aleatorizado, doble ciego, cruzado de tres vías y controlado por placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blind, three-way cross-over, placebo controlled study to assess the efficacy, safety and mechanisms of treatment with rupatadine 20 and 40 mg in cold contact urticaria (CCU)
    Función de la liberación de la Histamina y del factor de activación plaquetario (PAF) en la inflamación cutánea después de la provocación con agua fría en pacientes con urticaria por contacto al frío (CCU) tratados con rupatadina 20 y 40 mg. Estudio aleatorizado, doble ciego, cruzado de tres vías y controlado por placebo
    A.3.2Name or abbreviated title of the trial where available
    PAFCUTIII
    PAFCUTIII
    A.4.1Sponsor's protocol code numberPAFCUTIII
    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 SponsorConsorci Mar Parc de Salut de Barcelona
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJ. Uriach y Compañía, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Mar Parc de Salut de Barcelona
    B.5.2Functional name of contact pointAna Gimenez-Arnau
    B.5.3 Address:
    B.5.3.1Street AddressDr. Aiguader, 88
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933160678
    B.5.5Fax number0034934144909
    B.5.6E-mail22505aga@comb.es
    B.Sponsor: 2
    B.1.1Name of SponsorDepartment of Dermatology and Allergy Charité- Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportJ. Uriach y Compañía S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Dermatology and Allergy Charité- Universitätsmedizin Berlin
    B.5.2Functional name of contact pointDepartment of Dermatology and Aller
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz, 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-10117
    B.5.3.4CountryGermany
    B.5.4Telephone number004930450 51 80 43
    B.5.5Fax number004930450 51 89 72
    B.5.6E-mailMarcus.Maurer@charite.de
    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 Rupafin 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderJ. Uriach y Compañia, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namerupatadina 10 mg
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 182349-12-8
    D.3.9.2Current sponsor codeRupatadina
    D.3.9.3Other descriptive nameRUPATADINE FUMARATE
    D.3.9.4EV Substance CodeSUB22090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 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
    Cold contact urticaria
    Urticaria por contacto al frío
    E.1.1.1Medical condition in easily understood language
    Cold contact urticaria
    Urticaria por contacto al frío
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 assess the effects of rupatadine 20 mg and 40 mg on symptom development during the induction of skin lesions in CCU patients challenged with defined temperatures
    Evaluar los efectos de rupatadina 20 mg y 40 mg sobre el desarrollo de los síntomas durante la inducción de lesiones cutáneas en pacientes CCU tras provocación con temperaturas definidas
    E.2.2Secondary objectives of the trial
    To assess the effects of rupatadine on mast cell mediator release in blood during the induction of skin lesions in CCU patients challenged with cold water bath provocation with defined temperatures. Mediator measurements will include histamine and other mast cell-derived inflammation markers (e.g. PAF/LysoPAF, PGD2)
    To assess the effect of rupatadine on mast cell activation in the skin of CCU patients
    To assess the safety and tolerability of rupatadine
    Evaluar los efectos de rupatadina sobre la liberación del mediador de mastocitos en sangre durante la inducción de lesiones cutáneas en pacientes CCU, tras provocación con baño de agua fría a temperaturas definidas. Las mediciones del mediador incluirán histamina y otros mastocitos derivados de marcadores de inflamación (p.ej. PAF/ LysoPAF, PGD2).
    Evaluar el efecto de rupatadina sobre los mastocitos en la activación de éstos sobre la piel de los pacientes CCU.
    Evaluar seguridad y tolerabilidad de rupatadina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Informed consent signed and dated
    ?Reliable method of contraception for women of childbearing potential during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
    ?Outpatients with CCU for more than 6 weeks. confirmed by positive response with wheal and itch on Temptest®
    ?Age 18 and above years.
    ?No participation in other clinical trials 1 month before and after participation in this study
    ?Consentimiento Informado firmado y fechado
    ?Método de contracepción fiable para mujeres en edad fértil durante el ensayo y en los 3 meses posteriores. Se definen como métodos altamente efectivos de control de la natalidad aquellos que tienen una baja tasa de fallos (p.ej. menos de 1% por año) al ser usado de forma continuada y correcta, tales como implantes, inyectables, contraceptivos orales combinados, algunos DIUs, abstinencia sexual o presencia de una pareja masculina vasectomizada.
    ?Pacientes con CCU durante más de 6 semanas, confirmados tras respuesta positiva con pápulas y picazón por Temptest®
    ?Edad mayor o igual a 18 años.
    ?No haber participado en otros ensayos clínicos en el mes anterior a la participación en este.
    E.4Principal exclusion criteria
    ?Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
    ?The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
    ?The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
    ?History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
    ?History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
    ?ECG alterations of repolarisation (QTc prolongations > 450ms)
    ?Blood pressure >180/100 mmHg and/or heart rate >100/min.
    ?Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
    ?History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds

    ?Presence of active cancer which requires chemotherapy or radiation therapy
    ?Presence of lactose and galactose intolerance or glucose-galactose malabsorption
    ?Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment.

    ?Intake of antihistamines or antileukotrienes within 7 days before beginning of the study

    ?Intake of oral or depot corticosteroids within 14 days prior to screening visit

    ?Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
    ?Use of ketoconazole, erythromycin or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450

    ?Currently abusing drugs or alcohol

    ?Unwilling or unable to comply with the protocol

    ?Pregnancy or breast-feeding
    ?Sujetos que están en instituciones psiquiatritas, prisiones u otras instituciones similares. Ingreso previsto o actual en una institución tras estar de acuerdo con el párrafo 40 pasaje 1, numero 4 AMG.
    ?La presencia de enfermedades severas permanentes que afectan especialmente al sistema inmune, excepto urticaria y urticaria por frío.
    ?La presencia de enfermedades gastrointestinales permanentes las cuales puedan influenciar la terapia oral (diarrea crónica, malformaciones congénitas o mutilaciones quirúrgicas del tracto intestinal).
    ?Historia o presencia de epilepsia, desordenes neurológicos significativos, ataques cerebro-vasculares o isquemia.
    ?Historia o presencia de infarto de miocardio o arritmia cardíaca los cuales requieran terapia de medicamentos.
    ?Alteraciones de la repolarización del ECG (prolongaciones del QTc > 450ms)
    ?Presión sanguínea >180/100 mmHg y/o frecuencia cardíaca >100/min.
    ?Evidencia de enfermedad renal o hepática (GOT y/o GPT 3 veces superior al valor de referencia, creatinina sérica 1.5 veces superior al valor superior de referencia)

    ?Historia de hipersensibilidad o reacción alérgica a rupatadina o a otros compuestos antihistaminicos.

    ?Presencia de cáncer activo el cual requiera quimioterapia o terapia de radiación.
    ?Presencia de intolerancia a lactosa y galactosa o mala absorción de galactosa.
    ?Urticaria tanto crónica como espontánea simultáneamente, que pueda interferir con la evaluación de CCU

    ?Toma de antihistaminas o antileucotrienos dentro de los 7 días previos al inicio del ensayo.

    ?Toma de corticosteroides orales o depot dentro de los 14 días previos a la visita de screening.
    ?Uso de inmunosupresores/inmunomoduladores sistémicos tales como ciclosporina A, dapsona, metotrexato, micofenolato, cloroquina y medicamentos comparables dentro de los 28 días previos a la visita de screeening.
    ?Uso de ketoconazol, eritromicina o inhibidores potenciales del isoenzima CYP3A4 del citocromo P450.

    ?Abuso actual de drogas o alcohol.

    ?No desear o no ser capaz de cumplir con el protocolo.

    ?Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    -Change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of rupatadine (20 mg and 40 mg) measured by Temptest® 3.0
    -Cambio en el umbral del tiempo de estimulación (CSTT) y umbrales de temperatura critica (CTT) tras tratamiento con diferentes dosis de rupatadina (20 mg y 40 mg) medidos por Temptest® 3.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2, visit 3, visit 4, visit 5
    Visita 2, visita 3, visita 4, visita 5
    E.5.2Secondary end point(s)
    -Change in mast cell mediator release, including histamine, PAF/LysoPAF and PGD2 after treatment with rupatadine (20 and 40 mg) compared to placebo
    -Change in mast cell activation (measured by intracutaneous codeine, histamine and PAF injection)
    -Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting
    -Cambio en la liberación del mediador de los mastocitos, incluyendo histamina, PAF/LysoPAF y PGD2 tras tratamiento con rupatadina (20 y 40 mg) comparado con placebo.
    -Cambio en la activación de mastocitos (medida por inyección de codeína intracutánea, histamina y de PAF).
    -Seguridad y tolerabilidad. Esto incluye examen físico, valoraciones rutinarias de seguridad de laboratorio, observación clínica, signos vitales y reporte de efectos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3, visit 4, visit 5
    Visita 3, visita 4, visita 5
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cruzado de tres vías
    Three way crossover
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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 subject last visit
    Ultima visita del ultimo sujeto
    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 months3
    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 months3
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    All patients included in the trial which may have ended their participation (either in an anticipated way or not) will be treated in Dermatology Service if needed.
    A todos los pacientes que hayan sido incluidos en el ensayo clínico y que lo hayan finalizado (ya sea de manera anticipada o no) se les realizará un seguimiento en el Servicio de Dermatología.
    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 Decision2012-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-02
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