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    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-003542-17
    Sponsor's Protocol Code Number:CU-LATER
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-16
    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 number2013-003542-17
    A.3Full title of the trial
    A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with rupatadine
    Estudio en fase III, multicéntrico, aleatorizado, doble ciego, con escalado de dosis para evaluar la eficacia, la seguridad y los efectos a largo plazo del tratamiento con Rupatadina como medicación diaria fija vs. medicación a demanda en pacientes con urticaria crónica espontánea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with rupatadine
    Estudio en fase III, multicéntrico, aleatorizado, doble ciego, con escalado de dosis para evaluar la eficacia, la seguridad y los efectos a largo plazo del tratamiento con Rupatadina como medicación diaria fija vs. medicación a demanda en pacientes con urticaria crónica espontánea
    A.4.1Sponsor's protocol code numberCU-LATER
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportGA²LEN e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar
    B.5.2Functional name of contact pointDra. Ana Giménez-Arnau
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim de la Barceloneta, 25
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number34670 40 95 92
    B.5.5Fax number3493414 49 09
    B.5.6E-mail22505aga@comb.cat
    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 comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderJ.Uriach Cia., 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.3.4Pharmaceutical 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.3.8INN - Proposed INNRupatadine
    D.3.9.1CAS number 182349-12-8
    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
    Chronic Spontaneous Urticaria
    Urticaria crónica espontánea
    E.1.1.1Medical condition in easily understood language
    Chronic Spontaneous Urticaria
    Urticaria crónica espontánea
    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 compare CSU disease activity at the end of the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    Comparar la actividad de la urticaria crónica espontanea (CSU) al final de la fase de seguimiento, entre los pacientes que han sido tratados con terapia diaria continuada y los que han sido tratados con terapia a demanda.
    E.2.2Secondary objectives of the trial
    -To compare CSU disease activity during the follow up phase between patients with response vs. non-response at the end of the treatment phase.
    -To compare CSU disease activity during the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    -To compare the efficacy of rupatadine 10 mg during the treatment phase between patients treated daily continuously vs. on-demand.
    -To assess the efficacy of rupatadine 20 mg in CSU patients who not show complete symptom control with the 10 mg dose.
    -Evaluation of the safety profile of the rupatadine 20 mg dose.
    -Comparar la actividad de la CSU, durante la fase de seguimiento entre los pacientes con respuesta y los pacientes sin respuesta al final de la fase de tratamiento.
    -Comparar la actividad de la CSU entre los pacientes tratados diariamente en la fase de seguimiento y aquellos tratados a demanda.
    -Comparar la eficacia de rupatadina 10 mg entre los pacientes tratados diariamente y aquellos tratados a demanda durante la fase de tratamiento.
    -Evaluar la eficacia de rupatadina 20 mg en pacientes con CSU que no muestran un control completo de los síntomas con la dosis de 10 mg.
    -Evaluación del perfil de seguridad de la dosis de rupatadina 20 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female aged 18 years and older
    -Documented history of active CSU (urticaria and wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to visit 1 (screening). Urticaria symptoms must comprise wheals and itch
    -UAS7 of >=6 during the screening phase
    -Overall duration of chronic spontaneous urticaria for at least 3 months
    -Informed consent signed and dated
    -Able to read, understand and willing to sign the informed consent form and abide with study procedures
    -Willing, committed and able to return for all clinic visits and complete all study-related procedures
    -In females of childbearing potential: negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1) a woman will be considered not of childbearing potential if she is post-menopausal for > 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
    -No participation in other clinical trials 4 weeks before and after participation in this study
    -Varones o mujeres de 18 o más años de edad.
    -Historia documentada de CSU activa (urticaria y habones) con o sin un angioedema asociado como mínimo 3 días por semana durante las últimas 6 semanas previas a la visita 1 (screening). Los síntomas de urticaria han de presentar habones y picor.
    -UAS7 de >=6 durante la fase de screening
    -Duración total de la urticaria crónica espontánea de al menos 3 meses.
    -Consentimiento informado firmado y fechado.
    -Ser capaz de leer, entender y tener intención de firmar el consentimiento informado y consentir con los procedimientos del ensayo.
    -Con voluntad, comprometido y capaz de volver al centro para las visitas clínicas y completar todos los procedimientos propios del ensayo.
    -En mujeres fértiles: test de embrazo negativo, que usen métodos contraceptivos altamente efectivos (Pearl-Index < 1): una mujer será considerada no fértil si es post-menopáusica durante más de 2 años o estéril quirúrgicamente (ligamento tubal bilateral, ooferoctomía bilateral o histerectomía).
    -No haber participado en otros ensayos clínicos durante las 4 semanas anteriores a la participación en este ensayo.
    E.4Principal exclusion criteria
    -Chronic spontaneous urticaria patients with a known resistance to nsAH in 4 times the licensed doses
    -Chronic spontaneous urticaria patients with a known resistance to rupatadine
    -Isolated presence or domination of inducible forms of urticaria or cholinergic urticaria (no chronic spontaneous urticaria)
    -History of adverse reactions to rupatadine or known hypersensitivity to rupatadine or its ingredients
    -Intake of oral corticosteroids or intravenously applied corticosteroids within 28 days prior to screening visit
    -Use of depot corticosteroids within 3 months prior to screening visit (inhaled corticosteroids are allowed)
    -Use of systemic immunosupressants/immunomodulators such as ciclosporin, dapsone, metotrexate, and comparable drugs within 28 days prior to screening visit.
    -Significant medical condition, in the opinion of the Investigator, rendering the patient immunocompromised or not suitable for a clinical trial
    -Significant concomitant illness, in the opinion of the Investigator, that would adversely affect the subject?s participation or evaluation in this study
    -Subjects for whom there is concern, in the opinion of the Investigator, about compliance with the protocol procedures
    -The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
    -Presence of active cancer which requires chemotherapy or radiation therapy
    -History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
    -History or presence of myocardial infarction or acute myocardial ischemia
    -History or presence of cardiac arrhythmia which requires drug therapy
    -History or presence of clinically significant bradycardia (<50 bpm)
    -ECG alterations of repolarisation (QTc prolongations >450ms in females, >430ms in males)
    -Blood pressure >180/100 mmHg and/or heart rate >100/min
    -Presence of uncorrected hypokalemia or hyperkalemia
    -Evidence of significant hepatic or renal disease (GOT and/or GPT >2 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
    -Presence of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    -Medication with HMG-CoA reductase inhibitors (statins)
    -Presence of alcohol abuse or drug addiction
    -Pregnancy or breast-feeding
    -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).
    -Pacientes con urticaria crónica espontánea, con resistencia conocida a nsAH de 4 veces las dosis prescritas.
    -Pacientes con urticaria crónica espontánea, con resistencia conocida a Rupatadina.
    -Presencia aislada o dominancia de formas inducibles de urticaria o urticaria colinérgica (no urticaria crónica espontánea).
    -Historia de reacciones adversas a rupatadina o hipersensibilidad conocida al producto o a alguno de sus excipientes.
    -Toma de corticoesteroides orales o bien corticoesteroides aplicados por vía intravenosa dentro de los 28 días anteriores a la visita de screening.
    -Uso de corticoesteroides depot dentro de los 3 meses previos a la visita de screening (se permiten los corticoesteroides inhalados).
    -Uso de inmunosupresores/inmunomoduladores sistémicos tales como ciclosporina, dapsona, metotrexato y fármacos comparables, dentro de los 28 días previos a la visita de screening.
    -Enfermedad significativa que, a criterio del investigador, lleve al paciente a estar inmunodeprimido, o no se considere adecuado para el ensayo.
    -Enfermedad concomitante significativa que, en opinión del investigador, pudiera afectar negativamente en la participación y la evaluación de los datos del paciente en el ensayo.
    -Sujetos sobre los cuales haya dudas, según el investigador, de que cumplan con los prodecimientos del protocolo.
    -Presencia de enfermedad gastrointestinal permanente, la cual pueda interferir en la administración oral (diarrea crónica, malformaciones congénitas o mutilaciones quirúrgicas del tracto gastrointestinal).
    -Presencia de cáncer activo que requiera quimioterapia o radioterapia.
    -Historia o presencia de epilepsia, trastornos neurológicos significativos, ataques cerebrovasculares o isquemia.
    -Historia o presencia de infarto de miocardio o isquemia de miocardio aguda.
    -Historia o presencia de arritmia cardiaca que requiere la terapia con medicamentos.
    -Historia o presencia de bradicardia clínicamente significativa (<50 ppm).
    -Alteraciones del ECG de repolarización (prolongaciones de QTc> 450 ms en mujeres,> 430ms en varones).
    -Presión arterial> 180/100 mmHg y / o frecuencia cardíaca> 100/min.
    -Presencia de hipopotasemia no corregida o hiperpotasemia.
    -Evidencia de enfermedad hepática o renal significativa (GOT y / o GPT> 2 veces por encima del valor de referencia superior, creatinina sérica 1,5 veces por encima del valor de referencia superior).
    -Presencia de intolerancia a la galactosa, deficiencia de lactasa de Lapp o malabsorción de glucosa-galactosa.
    -Medicación con inhibidores de la HMG-CoA reductasa (estatinas)
    -Presencia de abuso de alcohol o adicción a drogas.
    -Embarazo o lactancia.
    -Sujetos ingresados en centros psiquiátricos, prisiones, u otras instituciones similares. Ingreso próximo o presente en una institución tras cumplir con el § 40 párrafo 1, numero 4 AMG (Arzneimittelgesetz).
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the UAS7 values (change from baseline) at the end of the follow-up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    Comparación de los valores de UAS7 (cambio respecto el basal), al final de la fase de seguimiento entre aquellos pacientes que han sido tratados diariamente, y aquellos que han sido tratados a demanda durante la fase de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 15-16
    Semana 15-16
    E.5.2Secondary end point(s)
    -Comparison of the UAS7 values (change from baseline) during the follow-up phase between patients with response vs. non-response at the end of the treatment phase.
    -Comparison of the UAS7 values (change from baseline) during the follow-up phase (period from week 10 to week 14) between patients that had been treated daily continuously vs. on-demand in the treatment phase.
    -Comparison of the UAS7 values (change from baseline) during the treatment phase (week 4, treatment with rupatadine 10 mg) between patients treated daily continuously vs. on-demand.
    -Comparison of the UAS7 values (change from baseline) during the treatment phase between patients treated daily continuously vs. on demand during weeks 5 to 10.
    -Comparison of the UAS7 values during treatment with rupatadine 10 mg and treatment with rupatadine 20 mg in patients who received an updosing of rupatadine (paired analysis).
    -Comparison of the proportion of patients with response (based on the UAS7) during the follow up phase in patients treated daily continuously vs on-demand in the treatment phase and in patients with response vs. non-response at the end of the treatment phase.
    -Assessment of the safety and tolerability of rupatadine 20 mg (based on the physical examinations, vital signs, clinical observations, monitoring lab, and adverse event reporting)
    -Comparación de los valores UAS7 (cambio respecto el basal), durante la fase de seguimiento, entre los pacientes con respuesta y aquellos sin respuesta al final de la fase de tratamiento.
    -Comparación de los valores UAS7 (cambio respecto el basal), durante la fase de seguimiento (periodo desde la semana 10 a la semana 14), entre los pacientes que han sido tratados diariamente frente a aquellos tratados a demanda durante la fase de tratamiento.
    -Comparación de los valores UAS7 (cambio respecto el basal), durante la fase de tratamiento (semana 4, tratamiento con rupatadina 10 mg) entre pacientes tratados diariamente frente a aquellos con tratados a demanda.
    -Comparación de los valores UAS7 (cambio respecto el basal), durante la fase de tratamiento, entre pacientes tratados diariamente frente a aquellos tratados a demanda, durante las semanas 5 a 10.
    -Comparación de los valores UAS7 durante el tratamiento con rupatadina 10 mg y el tratamiento con rupatadina 20 mg en pacientes que recibieron una dosis superior de rupatadina (análisis pareado).
    -Comparación de la proporción de pacientes con respuesta (basada en el UAS7), durante la fase de seguimiento en pacientes tratados continuamente frente a aquellos tratados a demanda en la fase de tratamiento y en pacientes con respuesta frente a aquellos sin respuesta al final de la fase de tratamiento.
    -Evaluación de la seguridad y tolerabilidad de rupatadina 20 mg (en base a los exámenes físicos, signos vitales, observaciones clínicas, laboratorio de monitorización y notificación de reacciones adversas)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 11-16, Weeks 11-14, Week 4, Weeks 5-10, Week 4 vs. Week 10, Weeks 11-16
    Semanas 11-16, semanas 11-14, semana 4, semanas 5-10, semana 4 vs. semana 10, semanas 11-16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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)
    After the completion of the study for a patient, the patient will receive continued treatment in the clinic, offerring a therapy as part of standard care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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