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    Summary
    EudraCT Number:2006-004230-32
    Sponsor's Protocol Code Number:CMA-0402-PR-0005
    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:2007-09-26
    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 number2006-004230-32
    A.3Full title of the trial
    EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA.
    ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS.
    A.3.2Name or abbreviated title of the trial where available
    Estudio BETA
    A.4.1Sponsor's protocol code numberCMA-0402-PR-0005
    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 SponsorChiesi Farmaceutici SpA
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name Clipper
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi España 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 Modified-release 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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534098
    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.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 Deltacortene
    D.2.1.1.2Name of the Marketing Authorisation holderBruno Farmaceutici SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNPREDNISONE
    D.3.9.1CAS number 53032
    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.IMP: 3
    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 Deltacortene
    D.2.1.1.2Name of the Marketing Authorisation holderBruno Farmaceutici SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNPREDNISONE
    D.3.9.1CAS number 53032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboModified-release tablet
    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
    Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 de eficacia es demostrar que la respuesta al tratamiento, medida en términos de DAI después de 4 semanas de tratamiento, no es inferior en el grupo de BDP comparado con el grupo de prednisona.

    - El objetivo principal de seguridad es demostrar un mejor perfil de seguridad en cuanto a toxicidad de esteroides y reducción de la producción de cortisol endógeno en el tratamiento de BDP, comparado con el tratamiento de prednisona.
    Los dos objetivos principales se evaluarán a las 4 semanas de tratamiento (duración normal de tratamiento).
    E.2.2Secondary objectives of the trial
    - Evaluación de la eficacia de los dos tratamientos en cuanto a mejoras de los síntomas relacionados con la enfermedad, estado general y gravedad de la enfermedad, medida en la semana 4 y la semana 8;

    - Evaluación del perfil de seguridad general de los dos regimenes de tratamiento después de 4 y 8 semanas de tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión en la visita de selección

    1. Hombres o mujeres, de cualquier origen étnico, de 18-70 años de edad ambos incluidos.
    2. Mujeres esterilizadas quirúrgicamente o en periodo postmenopaúsico desde hace al menos 12 meses, o dispuestas a practicar un control de la natalidad desde la visita de selección/inicial durante todo el periodo del estudio y hasta 30 días después de la última dosis de la medicación del estudio.
    3. Antecedentes de colitis ulcerosa documentada, con fecha anterior a 3 meses;
    4. Mesalazina oral, si está presente en el tratamiento actual, a dosis estable en los 14 días anteriores a la inclusión en el estudio, a una dosis máxima de 3,2 g/día. Para los pacientes bajo tratamiento con otra medicación oral que contenga 5-ASA, la dosis máxima permitida a la inclusión en el estudio es: balsalazida 6,75 g/día, olsalazina 2 g/día, sulfasalazina 3 g/día.
    5. Capaces de comprender y seguir los requisitos del protocolo;
    6. Habiendo otorgado consentimiento informado por escrito para la participación en el estudio.

    Criterios de inclusión en la aleatorización
    1. Puntuación endoscópica ≥ 1 confirmación de colitis ulcerosa activa en uno o más segmentos del colon;
    2. DAI  3 y <10;
    3. Puntuación de hemorragia rectal  1 (según la puntuación DAI);
    4. Sin modificaciones en las medicaciones concomitantes permitidas en la visita de selección;
    5. Prueba de embarazo negativa para mujeres.
    E.4Principal exclusion criteria
    Criterios de exclusión en la visita de selección
    1. Mujeres en edad fértil que no utilicen métodos anticonceptivos adecuados;
    2. Mujeres embarazadas o lactantes;
    3. Colitis ulcerosa grave;
    4. Megacolon tóxico;
    5. Colitis infecciosa;
    6. Colitis isquémica;
    7. Colitis provocada por fármacos o radioterapia;
    8. Enfermedad de Crohn;
    9. Cirugía gastrointestinal mayor diferente de apendicectomía;
    10. Úlcera péptica activa evolutiva o antecedentes médicos de complicaciones de úlcera péptica;
    11. Diabetes mellitus no compensada;
    12. Hipertensión arterial no controlada (TAS > 160 mm hg y/o TAD > 100 mm Hg);
    13. Hipertiroidismo;
    14. Antecedentes médicos de cáncer u otra enfermedad concomitante que, según la opinión del investigador, pueda interferir con la evaluación de los fármacos de prueba;
    15. Infecciones pulmonares poco controladas (tuberculosis, infecciones micóticas activas);
    16. Antecedentes de abuso de drogas o alcohol;
    17. Aleatorización previa en este estudio clínico;
    18. Pacientes que participaron en otro ensayo clínico en los 3 meses anteriores;
    19. Alergia, sensibilidad o intolerancia a los fármacos del estudio o sus excipientes
    20. Pacientes recibiendo corticosteroides orales o inyectables (incluida la budesonida oral) dentro de los 30 días anteriores a la visita de selección o corticosteroides rectales (supositorios, enemas, espumas) o inhalados, en los 14 días anteriores a la visita de selección;
    21. Cambio en la dosis del tratamiento de mesalazina oral, en los 14 días anteriores a la visita de selección o a una dosis superior a 3,2 g/día, y cambios en la dosis de otros tratamientos que contengan 5-ASA en los 14 días anteriores a la visita de selección, o a una dosis superior a 6,75 g/día para balsalazida, 2 g/día para olsalazina y 3 g/día para sulfalsalazina.
    22. Pacientes que estén siendo tratados con antagonistas del receptor H2 o inhibidores de la bomba de protones en las 2 semanas anteriores;
    23. Medicación con efecto secundario conocido de hipocalemia en los 14 días anteriores a la aleatorización;
    24. Tratamiento antibiótico que no se pueda parar antes de la aleatorización;
    25. Uso de inmunomoduladores o inmunodepresores en los 3 meses anteriores;
    26. Pacientes tratados con antagonistas TNF- en los 6 meses anteriores;
    27. Uso de AINE, diferentes de ácido acetilsalicílico en dosis bajas para tratamiento antiplaquetario.

    Criterios de exclusión en la aleatorización
    1. Pacientes que tengan colitis ulcerosa grave, definida como DAI ≥ 10 que necesite tratamiento inmunosupresor incluyendo corticosteroides u hospitalización;
    2. Examen positivo de huevos y parásitos en heces;
    3. Colitis ulcerosa con puntuación endoscópica < 1 o puntuación de hemorragia rectal < 1;
    4. Colitis ulcerosa limitada al recto, confirmada mediante examen endoscópico;
    5. Insuficiencia hepática significativa (AST o ALT dos veces por encima del límite superior normal);
    6. Insuficiencia renal significativa (creatinina sérica > 1,5 mg/dl);
    7. Cualquier prueba de laboratorio anormal que pueda interferir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - La variable principal de eficacia será el porcentaje de pacientes con respuesta clínica, definido como una puntuación de DAI < 3 o reducida al menos 3 puntos para pacientes con un DAI inicial ≥ 7 después de 4 semanas de tratamiento con el fármaco del estudio.

    - La variable principal de seguridad será el porcentaje de pacientes con AAs relacionados con el tratamiento esteroide incluyendo cortisol sérico por la mañana < 5 mcg/dl (o <150 nmol/l) durante las 4 primeras semanas de tratamiento (desde la visita 2 hasta la visita 4
    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) 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 No
    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 EEA40
    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
    Last visit of last patient 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 months10
    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 months10
    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 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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 300
    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 Decision2007-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-02
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