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    Summary
    EudraCT Number:2010-019888-10
    Sponsor's Protocol Code Number:B1531002
    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:2010-10-13
    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 number2010-019888-10
    A.3Full title of the trial
    PROSPECTIVE OPEN-LABEL INVESTIGATION OF THE NON-SURGICAL TREATMENT WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAPEX®) (X)
    INVESTIGACIÓN PROSPECTIVA ABIERTA DEL TRATAMIENTO NO QUIRÚRGICO CON COLAGENASA DE CLOSTRIDIUM HISTOLYTICUM XIAPEX® (X)
    A.4.1Sponsor's protocol code numberB1531002
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 nameXiapex®
    D.3.2Product code PF-05076985
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSAN: collagenase clostridium histolyticum
    D.3.9.1CAS number 955049-04-0
    D.3.9.2Current sponsor codePF-05076985
    D.3.9.3Other descriptive nameXiapex
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dupuytren?s contracture
    Contractura de Dupuytren
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10013873
    E.1.2Term Dupuytren's contracture operation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Se evaluará el impacto de Xiapex® en la contractura de Dupuytren, el rango de movimiento (RDM) y la satisfacción comunicada por el paciente y el médico con respecto al tratamiento, así como la intensidad de la enfermedad y su relación con el rango de movimiento.
    -Se valorará la recuperación de las actividades normales.
    -El tiempo de recuperación (duración global, tiempo hasta la utilización de la mano, tiempo transcurrido hasta la vuelta al trabajo o las actividades diarias, la cantidad de trabajo o de tiempo de actividad diaria perdidos o reducidos y efectos sobre la productividad y las actividades diarias)-valorados a través del diario del paciente.
    -Uso de analgésicos concomitantes.
    -Se evaluará la utilización de recursos de atención sanitaria totales (URAST) (por ejemplo, visitas y recursos médicos y de atención sanitaria relacionada, utilización de férulas).
    -Se valorará el patrón de tratamiento cuando se someten a tratamiento múltiples articulaciones o dedos.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Como mínimo 18 años de edad e igual o inferior a 70 años.
    2. Que presenten una contractura de Dupuytren de como mínimo 20º causada por una cuerda palpable al menos en un dedo distinto del pulgar.
    3. ?Prueba de escritorio? positiva, definida como la incapacidad para colocar simultáneamente los dedos afectados y la palma planos contra la superficie de una mesa.
    4. Si se goza de buena salud, según los resultados de la historia clínica, exploración física y perfil analítico de seguridad.
    5. Las pacientes fértiles deben utilizar un método aceptable de control de la natalidad o estar quirúrgicamente esterilizadas o ser posmenopáusicas (es decir, sin reglas durante como mínimo un año). Se realizará una prueba de embarazo antes del reclutamiento en el estudio.
    6. Evidencia de un documento de consentimiento informado personalmente firmado y fechado indicando que el paciente (o un representante legalmente aceptable) ha sido informado de todos los aspectos pertinentes del estudio.
    7. Pacientes que estén dispuestos y sean capaces de cumplir las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Embarazo o lactancia, o planificación de quedarse embarazada durante la fase de tratamiento.
    2. Ha tomado un medicamento en fase experimental en los 30 días previos a la primera dosis del fármaco del estudio.
    3. Ha recibido tratamiento en la articulación seleccionada para la contractura de Dupuytren en los 90 días previos al reclutamiento en el estudio, incluida una aponeurotomía de aguja o cualquier procedimiento quirúrgico.
    4. Pacientes con una hipersensibilidad sistémica conocida a la colagenasa o a cualquiera de los demás excipientes del producto.
    5. En tratamiento anticoagulante o ha recibido anticoagulantes (excepto aspirina, menos de 150 mg diarios) en los siete días previos a la primera inyección.
    6. Tiene antecedentes médicos o dolencias clínicamente significativos, entre ellos enfermedades que afecten a las manos que, en opinión del investigador, aumentarían de manera sustancial el riesgo asociado con la participación del paciente en el protocolo o pondrían en riesgo los objetivos científicos del estudio.
    7. Tiene una enfermedad muscular, neurológica o neuromuscular crónica que afecta a las manos
    8. Otras enfermedades psiquiátricas o médicas crónicas o agudas significativas o anomalías analíticas que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en fase experimental o que puedan interferir en la interpretación de los resultados del estudio y que, a juicio del investigador, harían que el paciente no fuera adecuado para su inclusión en este estudio.
    9. Lleve en la mano que debe tratarse joyas que no puedan retirarse.
    E.5 End points
    E.5.1Primary end point(s)
    Seguridad:
    -Acontecimientos adversos, constantes vitales, variables analíticas clínicas y ADA.
    Eficacia:
    -DEPT y PED* (difícil de extensión pasiva total: una suma de los déficit de extensión pasivos (DEP) en las articulaciones MP, PIP y DIP).
    -Cambio el DEPT y el DEP para cada articulación tratada.
    -RDM.
    -Evaluación global del paciente y el médico de satisfacción con el tratamiento e intensidad de la enfermedad.
    Recuperación y URAST:
    -Tipo y cantidad de analgésicos concomitantes.
    -Tiempo de recuperación total, tiempo hasta utilización de la mano, las actividades diarias, trabajo con respecto a pasatiempos.
    -Cuestionario de utilización de recursos sanitarios.
    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 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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    definido en el protocolo
    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 months7
    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 months7
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    none
    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 Decision2010-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-31
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