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    Summary
    EudraCT Number:2008-006420-65
    Sponsor's Protocol Code Number:ASAC-CUPSLA-1-08
    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:2008-12-12
    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 number2008-006420-65
    A.3Full title of the trial
    Ensayo clínico piloto, fase IV, unicéntrico, controlado, doble ciego, sobre los efectos del extracto de curcuma centrum estandarizado al 12% en curcumina + fototerapia local con luz visible en adultos diagnosticados de psoriasis en placas moderada-grave de al menos 6 meses de evolución
    A.4.1Sponsor's protocol code numberASAC-CUPSLA-1-08
    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 SponsorESPECIALIDADES FARMACÉUTICAS CENTRUM S.A.
    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 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 Yes
    D.2.1.1.1Trade name EXTRACTO DE CURCUMA CENTRUM
    D.2.1.1.2Name of the Marketing Authorisation holderCENTRUM, 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 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 INNCURCUMA EXTO SECO
    D.3.9.3Other descriptive nameCURCUMA EXTO SECO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis cronica en placas moderada-grave
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establecer el porcentaje de respondedores a la fototerapia local con luz visible, frente a la ausencia de ésta, en la zona que recibe directamente terapia fotosensibilizante UVA.
    Establecer el curso temporal de la respuesta a la fototerapia con luz visible.
    E.2.2Secondary objectives of the trial
    Registro de acontecimientos adversos.
    Evolución de las lesiones psoriásicas en las zonas que no reciben directamente terapia fotosensibilizante con UVA ni luz visible.
    Porcentaje de respondedores a la terapia fotosensibilizante UVA.
    Curso temporal de la respuesta a la terapia fotosensibilizante UVA.
    Nº de sesiones y cantidad total de radiación recibida hasta alcanzar la respuesta terapéutica a la terapia fotosensibilizante UVA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Individuos de ambos sexos que tras haber recibido información sobre el diseño, los fines del proyecto, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración y abandonar el estudio, otorguen por escrito su consentimiento para participar en el ensayo.
    2. Edad comprendida entre 18 y 65 años de edad.
    3. Deben presentar un diagnóstico clínico de psoriasis en placas definida como moderada-grave, desde al menos 6 meses antes de la selección para el estudio (Anexo I).
    4. Los sujetos deben presentar en una extremidad una zona de lesiones psoríásicas en placas:
    a. susceptible de ser tratada en su conjunto con la cámara de aplicación de luz visible
    b. de una superficie tal que la suma de las áreas de las placas, calculada como el producto de sus ejes mayores, sea > 30 cm2, siendo la placa de menor tamaño > 4 cm2
    c. que según la valoración clínica global de la psoriasis para el médico se considere moderada a grave (marcada elevación de las placas, descamación y/o eritema).
    5. Los sujetos deben ser candidatos a fototerapia o tratamiento sistémico de la psoriasis
    6. No presentar anormalidades clínicamente relevantes en los análisis de hematología
    7. Niveles de aspartato aminotransferasa, alanina aminotransferasa, fosfatasa alcalina y gamma glutamiltransferasa < 1.5 veces el límite superior de la normalidad para los valores estándar del laboratorio
    8. Bilirrubina total < 1.5 veces el límite superior de la normalidad para los valores estándar del laboratorio
    9. Creatinina sérica < 1.5 mg/dl
    10. Test de embarazo negativo (para las mujeres).
    E.4Principal exclusion criteria
    1. Sujetos afectos de otras enfermedades clínicamente relevantes en grado moderado-severo
    2. Sujetos que presenten otras formas de psoriasis que no sea en placas
    3. Sujetos con psoriasis activa inducida por fármacos
    4. Mujeres embarazadas
    5. Sujetos que hayan recibido tratamiento farmacológico tópico o sistémico de la psoriasis en las 4 semanas anteriores.
    6. Sujetos que hayan recibido tratamiento fototerápico de la psoriasis en las 4 semanas anteriores.
    7. Mujeres en edad fértil en tratamiento con contraceptivos hormonales
    8. Antecedentes de hipersensibilidad a la cúrcuma o derivados
    9. Contraindicación para fototerapia UV-A
    10. Sujetos diagnosticados de trastornos del conducto biliar con bloqueo del mismo
    11. Antecedentes de cólico biliar en el año previo
    12. Sujetos que estén en una situación tal que, en opinión del investigador, pueda interferir en su participación óptima en el estudio
    13. Sujetos que estén participando en otro estudio con fármacos en investigación en los 3 meses previos.
    14. Incapacidad para seguir las instrucciones o colaborar durante el desarrollo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    a) Variable principal de evaluación para los objetivos primarios: se utilizará la valoración clínica global por el investigador (PGA) (Anexo III):
    a. Respondedores a la fototerapia con luz visible:
    i. PGA para la clasificación de los pacientes: Se calificará como respondedor al paciente con grado de “prácticamente limpio”, o “limpio”
    ii. PGA para la evaluación del cambio en relación con la afectación basal: Se calificará como respondedor al paciente con grado > excelente
    b. Curso temporal de la respuesta:
    i. Tiempo hasta alcanzar grado de PGA de “prácticamente limpio” o “limpio”, y cambio excelente respecto a la situación basal
    ii. Nº de sesiones de radiaciones hasta alcanzar grado de PGA de “prácticamente limpio” o “limpio”, y cambio de grado > excelente respecto a la situación basal
    b) Para los objetivos secundarios:
    a. Respondedores a fototerapia UVA: Se utilizarán dos variables para establecer el porcentaje de respondedores, siguiendo las recomendaciones de la Agencia Europea del Medicamento, excluyendo e incluyendo la zona no expuesta a la fototerapia UVA:
    i. Valoración clínica global por el investigador, calificando a los pacientes con el grado de “prácticamente limpio”, o “limpio”
    ii. Nº pacientes cuyo Índice de Superficie y Gravedad de la Psoriasis (PASI) mejore en más de un 75% sobre la basal (PASI > 75%)
    iii. Nº pacientes PASI > 90% (remisiones)
    b. Curso temporal de la respuesta a fototerapia UVA:
    i. Tiempo hasta alcanzar PASI > 75% y > 90%
    ii. Nº de sesiones de radiaciones hasta alcanzar PASI > 75% y > 90%
    c. Seguridad:
    i. Nº total de sesiones y cantidad total de radiación recibida
    ii. Acontecimientos adversos
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    EL ENSAYO EVALUARÁ LA RESPUESTA LOCAL A LA LUZ VISIBLE EN PACIENTES QUE RECIBEN EXT.CURCUMA + UVA
    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.8.5The trial involves multiple Member States No
    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 months6
    E.8.9.1In the Member State concerned days0
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    NO HAY PREVISTO EN EL PROTOCOLO TRATAMIENTO PARA LOS SUJETOS QUE FINALIZAN EL ENSAYO PERO LOS QUE ESTÉN INTERESADOS SE LES SOLICITARÁ EL USO COMPASIVO
    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 Decision2009-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
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