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    Summary
    EudraCT Number:2007-007087-17
    Sponsor's Protocol Code Number:A0221045
    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:2010-03-01
    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 number2007-007087-17
    A.3Full title of the trial
    A 24-WEEK, MULTICENTRE TRIAL, COMPRISING A 12-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE FOLLOWED BY A 12-WEEK OPEN-LABEL PHASE, TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER

    ENSAYO MULTICÉNTRICO DE 24 SEMANAS, FORMADO POR UNA FASE ALEATORIZADA, DOBLE CIEGO, CONTROLADA CON PLACEBO Y DE GRUPOS PARALELOS DE 12 SEMANAS, SEGUIDA DE UNA FASE DE TRATAMIENTO ABIERTO DE 12 SEMANAS, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE UNA PAUTA DE DOSIS FLEXIBLES DE FESOTERODINA EN PACIENTES DE EDAD AVANZADA CON VEJIGA HIPERACTIVA
    A.4.1Sponsor's protocol code numberA0221045
    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, S.A.
    B.1.3.4CountrySpain
    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 Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFesoterodine
    D.3.4Pharmaceutical form Prolonged-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 INNFesoterodine
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive nameFesoterodine Fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.2.1.1.1Trade name Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namefesoterodine
    D.3.4Pharmaceutical form Prolonged-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 INNFesoterodine
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive nameFesoterodine Fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 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
    Treatment of overactive bladder with symptoms of frequency, urgency, and urgency
    incontinence (Some patients will also have urgency urinary incontinence (UUI)).

    Tratamiento de la vejiga hiperactiva (VHA) con síntomas de frecuencia y urgencia urinarias. Algunos pacientes presentarán además incontinencia urinaria de urgencia (IUU).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia, valorada por la reducción de los episodios de urgencia, de una dosis flexible de fesoterodina administrada durante 12 semanas y de un placebo en sujetos ancianos con VHA.
    E.2.2Secondary objectives of the trial
    • Comparar el efecto de una pauta de dosis flexibles de fesoterodina durante 12 semanas y de un placebo sobre otros resultados comunicados por los pacientes en sujetos ancianos con VHA.
    • Evaluar la seguridad y la tolerabilidad de pautas de dosis flexibles de 12 semanas de fesoterodina en comparación con un placebo en sujetos ancianos con VHA.
    • Evaluar la seguridad, la tolerabilidad y la eficacia de una pauta abierta de dosis flexibles de fesoterodina en sujetos ancianos con VHA durante 12 semanas adicionales de tratamiento después de la fase doble ciego controlada con placebo.
    • Comparar la eficacia y la tolerabilidad de la administración de fesoterodina SR por la mañana y por la noche.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes ambulatorios de ambos sexos de edad ≥ 65 años.
    2. Síntomas de vejiga hiperactiva (notificados por el sujeto) durante ≥3 meses antes de la vista de selección/reclutamiento (visita 1) conforme a las directrices de la ICS.
    3. Frecuencia urinaria media ≥ 8 micciones cada 24 horas demostrada por el diario de micciones antes de la visita de aleatorización/basal (visita 2).
    4. Número medio de episodios de urgencia ≥3 cada 24 horas verificado con el diario de micciones de la selección antes de la visita 2/basal (los episodios de urgencia se definen como los que reciben una valoración ≥3 en la escala de sensación vesical).
    5. Valoración que indique que el trastorno vesical causa “algunos problemas moderados”, “problemas graves” o “muchos problemas graves” en el cuestionario de percepción del trastorno vesical por el paciente (PPBC) en la visita basal/visita 2.
    6. Pacientes que puedan y quieran rellenar los diarios de micciones y todos los cuestionarios relacionados con el ensayo y cumplir las visitas programadas a la consulta y los procedimientos del ensayo clínico.
    7. Puntuación ≥20 en el Miniexamen del estado mental.
    8. Pacientes capaces de entender que hayan firmado el consentimiento informado tras una explicación completa de la naturaleza experimental del tratamiento y de sus riesgos y efectos beneficiosos.
    9. Todas las mujeres incluidas en este ensayo deberán ser posmenopáusicas según la valoración del investigador.
    E.4Principal exclusion criteria
    1. Cualquier proceso que contraindique el uso de fesoterodina, como: hipersensibilidad al principio activo (fumarato de fesoterodina) o a los cacahuetes, la soja o cualquiera de los excipientes, retención urinaria, retención gástrica, glaucoma de ángulo estrecho no controlado, miastenia grave, insuficiencia hepática grave (Child-Pugh C), colitis ulcerosa grave y megacolon tóxico.
    2. Predominio de incontinencia de esfuerzo. Incontinencia urinaria de esfuerzo determinada/valorada por el investigador.
    3. Prolapso de órgano pélvico en estadio 3 o superior, definido como tejido visible a través del orificio en la posición de litotomía en reposo (sin aumento de la presión intraabdominal).
    4. Resección transuretral de la próstata (RTUP) o de la vejiga (RTUV) y otras intervenciones menores (p. ej., cistoscopia) realizadas en los 6 meses previos o antecedentes de intervención quirúrgica importantes en las vías urinarias inferiores (p. ej., cirugía para la incontinencia o prostatectomía radical) en cualquier momento.
    5. Antecedentes de cistitis interstiticial o de dolor significativo asociado a los síntomas de VHA, hematuria no investigada, cáncer urogenital, radiación interstiticial o externa de la pelvis o de los genitales externos, sospecha clínica de carcinoma de próstata, quistes de los conductos de Müller, cistitis por radiación o tuberculosis genitourinaria.
    6. Cálculos vesicales activos. Podrán participar los pacientes con antecedentes de cálculos vesicales.
    7. Antecedentes de retención urinaria aguda que requiere sonda o existencia de obstrucción de la salida de la vejiga clínicamente significativa o dificultades notables para la micción, a juicio del investigador.
    8. Uso de una sonda permanente o de un programa de autosondaje intermitente
    9. Infección urinaria (IU) activa demostrada por los resultados del análisis de orina en la selección o infección urinaria recurrente (IUR), definida como tratamiento de IU más de 3 veces en el último año Si se detecta IU durante la selección, podrá tratarse al sujeto (que permanecerá en el estudio dentro de un período de selección ampliado) y repetirse el análisis 2 semanas después de la conclusión del tratamiento.
    10. Uso de cualquier método de electroestimulación, entrenamiento vesical o ejercicios del suelo pélvico (con médicos especializados en incontinencia) en las 4 semanas previas a la visita 2.
    11. Esclerosis múltiple o lesión medular.
    12. Tratamiento con antimuscarínicos para la VHA en las 2 semanas anteriores a la visita 2, incluidos los preparados que contengan:
    • darifenacina, oxibutinina, propiverina, tolterodina y trospio
    13. Tratamiento con solifenacina en las 3 semanas anteriores a la visita 2.
    14. Uso intermitente o inestable de diuréticos o alfabloqueantes o comienzo de un tratamiento de este tipo en las 2 semanas anteriores a la visita 2.
    15. Tratamiento con inhibidores potentes de la CYP3A4, como claritromicina, ketoconazol e itraconazol en las 2 semanas anteriores a la visita 2 .
    16. Participación en un ensayo clínico o administración de cualquier fármaco experimental en las 4 semanas anteriores a la visita 2.
    17. Cualquier neoplasia maligna actual salvo:
    a. Las que se hayan producido > 5 años antes y no hayan recidivado.
    b. Carcinoma cutáneo basocelular o epidermoide extirpado.
    18. Otras enfermedades graves o agudas (como la diabetes mellitus de nuevo diagnóstico o la hipertensión de nuevo diagnóstico que requiera tratamiento, o los trastornos hematológicos o cardiovasculares importantes), o cualquier trastorno psicológico o circunstancia social que, en opinión del investigador, puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que puedan interferir en la interpretación de los resultados del estudio o alterar la capacidad de participar en él con garantías, o que puedan aumentar el riesgo para los pacientes o para terceros.
    19. Enfermedad hepática de importancia clínica y/o un valor de AST, ALT o GGT más de 2 veces mayor que el límite superior de la normalidad (LSN) en las pruebas de la selección.
    20. Nefropatía de importancia clínica en opinión del investigador y/o un valor de FGe menor de 45 ml/min.
    21. Abuso del alcohol o de cualquier fármaco o droga, en opinión del investigador
    22. Sujetos que, en opinión del investigador, es improbable que completen el ensayo por cualquier motivo.
    E.5 End points
    E.5.1Primary end point(s)
    • Variación numérica de los episodios de urgencia urinaria cada 24 horas en la semana 12 respecto al valor basal (los episodios de urgencia urinaria se definen como los que reciben una valoración ≥3 para la micción correspondiente en la escala de sensación urinaria del diario)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Double-Dummy
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    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 days
    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 days14
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 550
    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)
    Esto es un ensayo clínico. El fármaco en investigación, Fesoterodina y los procedimientos médicos descritos en el estudio, se proporcionarán a los pacientes sólo durante el estudio, al menos que los pacientes sufran un acontecimiento adverso, que requiera un seguimiento apropiado.
    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 Decision2008-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-08
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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