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    Summary
    EudraCT Number:2009-014870-16
    Sponsor's Protocol Code Number:BA2009-28-01
    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:2010-11-12
    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 number2009-014870-16
    A.3Full title of the trial
    Una fase II, ensayo multicentrico, randomizado, doble ciego, controlado por placebo que compara
    la eficacia y la tolerencia de Clonidine Lauriad 50 mcg y 100 mcg comprimido bucal mucoadhesivo administrado una vez por dia a un placebo en la prevencion y tratamiento de la mucositis oral inducida
    por quimioterapia y radioterapia en pacientes con cancer de cabeza y cuello
    A.4.1Sponsor's protocol code numberBA2009-28-01
    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 SponsorBioAlliance Pharma
    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 nameClonidine Lauriad
    D.3.2Product code BA028
    D.3.4Pharmaceutical form Muco-adhesive buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205907
    D.3.9.2Current sponsor codeBA028
    D.3.9.3Other descriptive nameClonidine Lauriad
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameClonidine Lauriad
    D.3.2Product code BA028
    D.3.4Pharmaceutical form Muco-adhesive buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205907
    D.3.9.2Current sponsor codeBA028
    D.3.9.3Other descriptive nameClonidine Lauriad
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 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 placeboMuco-adhesive buccal tablet
    D.8.4Route of administration of the placeboGingival use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevencion y tratamiento de la mucositis oral inducida por quimioterapia y radioterapia
    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 de Clonidine Lauriad® CBM de 50 μg y 100 μg frente a placebo en la prevención y el tratamiento de la mucositis oral inducida por radioquimioterapia.
    E.2.2Secondary objectives of the trial
    - Determinar la dosis óptima de Clonidine Lauriad® CBM
    - Determinar los parámetros farmacocinéticos plasmáticos y salivares de Clonidine Lauriad® CBM de 50 μg y 100 μg
    - Evaluar la calidad de vida de los pacientes oncológicos tratados con Clonidine Lauriad® CBM durante la radioquimioterapia
    - Evaluar la duración de la adhesión de CBM
    - Evaluar la seguridad local y global de Clonidine Lauriad® CBM
    - Evaluar de forma preliminar la farmacoeconomía de los pacientes sometidos a radioquimioterapia tratados con Clonidine Lauriad® CBM y placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombre o mujer
    2. Edad >18 años
    3. Carcinoma epidermoide recién diagnosticado de la cavidad bucal, bucofaringe, hipofaringe o laringe confirmado histológicamente y sometido a cirugía resectiva.
    4. Cirugía curativa más de 2 semanas y menos de 10 semanas antes del inicio de la RT-QT
    5. Que puedan recibir:
    a. Un ciclo continuo de radiación de haz externo tradicional (que cumpla los criterios para recibir IMRT) con una dosis de radiación acumulada mínima de 50 Gy y un máximo de 70 Gy, sobre la base de una dosis diaria entre 1,8 y 2,2 Gy. Los campos de radioterapia programados deben incluir al menos dos localizaciones de tejido bucal (entre la mucosa yugal, el suelo de la boca, la lengua y el paladar blando), recibiendo cada localización un total de 50 Gy o un máximo de 70 Gy. Un oncólogo radiólogo designado revisará el plan de radioterapia.
    y
    b. Quimioterapia consistente en la administración estándar de cisplatino o carboplatino administrados en ciclos estándar semanales o cada tres semanas.
    6. Estado funcional de ECOG ≤ 2
    7. Pruebas analíticas de la selección
    a. Hemoglobina ≥ 10 g/dl
    b. Recuento de leucocitos ≥ 3500 células/mm3
    c. Recuento absoluto de neutrófilos ≥ 1500 células/mm3
    d. Bilirrubina conjugada ≤ 2 veces el límite superior de la normalidad (LSN)
    e. AST y ALT en suero ≤ 3 LSN
    f. Creatinina sérica ≤ 2 mg/dl
    g. Prueba de embarazo en suero o en orina negativa
    8. Las mujeres en edad fértil deben usar un método anticonceptivo eficaz (oral o dispositivo)
    9. Firma del consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Tumores en los labios, senos paranasales, glándulas salivales
    2. Radiación previa de la zona de la cabeza y del cuello
    3. Tratamiento previo con quimioterapia
    4. Cirugía curativa menos de 2 semanas o más de 10 semanas antes del inicio de la RT-QT
    5. Presencia de enfermedad infecciosa activa
    6. Presencia de enfermedad infecciosa oral activa, como candidiasis bucofaríngea o herpes bucofacial
    7. Presencia de mucositis oral
    8. Enfermedades víricas crónicas comprobadas o sospechadas, como VIH
    9. Presión arterial sistólica < 100 mmHg o presión arterial diastólica < 50 mmHg
    10. Ictus reciente en los 6 últimos meses
    11. Bradiarritmia (< 60 l/min), incluida la alteración de la función del nódulo sinusal o bloqueo de conducción del nódulo AV de 2.º o 3.er grado
    12. Pacientes con hipotensión ortostática, definida por un descenso de la PA sistólica o una PA diastólica por encima de 20 mmHg cuando el paciente se pone de pie.
    13. Insuficiencia renal grave (nivel de creatinina en sangre > 1,5 LSN)
    14. Consumo intensivo de alcohol en la actualidad (> 100 g de alcohol/día)
    15. Administración de cualquier tratamiento concomitante que pueda interferir con la clonidina (véase el apartado 6.4)
    16. Hipersensibilidad comprobada a la clonidina, antecedentes de alergia o intolerancia a las proteínas de la leche o cualquier otro ingrediente del producto
    17. Presencia de depresión grave o no controlada
    18. Mujeres embarazadas o en período de lactancia
    19. Incapacidad para dar su consentimiento informado o cumplir con los requisitos del estudio
    20. Incapacidad o falta de disposición para realizar las visitas de seguimiento.
    21. Participación en un ensayo clínico en los 30 días previos a la aleatorización y durante todo el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    comparación entre los grupos del porcentaje de pacientes con una puntuación de la mucositis oral ≥ 3 usando la escala de la OMS a una dosis de radiación acumulada de 50 Gy
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    la ultima visita del ultimo sujeto reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 183
    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 es aplicable
    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 Decision2011-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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