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    Summary
    EudraCT Number:2010-022475-55
    Sponsor's Protocol Code Number:A0221047
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-26
    Trial 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 number2010-022475-55
    A.3Full title of the trial
    A 12-WEEK RANDOMIZED, OPEN-LABEL, ACTIVE COMPARATOR PERIOD FOLLOWED BY A 12-WEEK SAFETY EXTENSION PERIOD TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 16 YEARS AND >25 KG WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)
    PERIODO ALEATORIZADO Y ABIERTO DE 12 SEMANAS CON COMPARADOR ACTIVO SEGUIDO DE UN PERIODO DE EXTENSIÓN DE SEGURIDAD DE 12 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE FESOTERODINA EN SUJETOS DE 6 A 16 AÑOS Y >25 KG CON SÍNTOMAS DE HIPERACTIVIDAD DEL DETRUSOR ASOCIADA CON UN TRASTORNO NEUROLÓGICO (HIPERACTIVIDAD NEURÓGENA DEL DETRUSOR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study to find out how the medicine fesoterodine works in children aged 6 to 16 years with bladder overactivity caused by a neurological condition (such as spina bifida).
    Estudio de investigación para analizar cómo funciona el medicamento fesoterodina en niños de entre 6 y 16 años con vejiha hiperactiva causada por una condición neurológica (tipo espina bífida)
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA0221047
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer, S.L.U.
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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 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 Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 Fumarate
    D.3.9.1CAS number 286930-03-8
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 Fumarate
    D.3.9.1CAS number 286930-03-8
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Lyrinel XL
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code Oxybutynin hydrochloride
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 INNOxybutynin Hydrochloride
    D.3.9.1CAS number 5633-20-5
    D.3.9.2Current sponsor codeOxybutynin Hydrochloride
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 4
    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 Lyrinel XL
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code Oxybutynin hydrochloride
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 INNOxybutynin Hydrochloride
    D.3.9.1CAS number 5633-20-5
    D.3.9.2Current sponsor codeOxybutynin Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Neurogenic Detrusor Overactivity (NDO).
    Hioperactividad Neurógena del Detrusor (HND).
    E.1.1.1Medical condition in easily understood language
    Bladder overactivity caused by a neurological condition such as spina bifida, known medically as neurogenic detrusor overactivity.
    Hiperactividad de la vejiga causada por una condición neurológica como por ejemplo espina bífida, conocida clínicamente como hiperactividad neurógena del detrusor.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029279
    E.1.2Term Neurogenic bladder
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and efficacy of fesoterodine 4 mg and 8 mg following once daily treatment for 12 weeks in pediatric NDO subjects.
    Determinar la seguridad y la eficacia de fesoterodina 4 y 8 mg tras el tratamiento una vez al día durante 12 semanas en sujetos pediátricos con HND.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    ? evaluate the safety and efficacy of fesoterodine versus oxybutynin
    ? evaluate the safety of fesoterodine 4 mg and 8 mg once daily treatment for up to 24 weeks in pediatric neurogenic bladder subjects.
    ? determine the population pharmacokinetics of 5-HMT following fesoterodine 4 mg and 8 mg once daily treatment for 12 weeks in pediatric NDO subjects.
    Los objetivos secundarios de este estudio son:
    ? Evaluar la seguridad y la eficacia de fesoterodina en comparación con oxibutinina.
    ? Evaluar la seguridad del tratamiento con fesoterodina 4 y 8 mg una vez al día durante un máximo de 24 semanas en sujetos pediátricos con HND.
    ? Determinar la farmacocinética poblacional en estado de equilibrio de 5-HMT tras el tratamiento con fesoterodina 4 y 8 mg una vez al día en sujetos pediátricos con HND.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female subjects aged 6 to 16 years 11 months (age at time of first dose); that is subjects who have passed their sixth birthday but not reached their seventeenth birthday.
    2. A total body weight >25 kg (55 lbs).
    3. Subjects with stable neurological disease and clinically- or urodynamically-demonstrated NDO, confirmed urodynamically at Visit 2, by detrusor overactivity or decreased bladder compliance, with decreased maximum cystometric bladder capacity.
    NOTE: Subjects with hypocontractile bladder, detrusor underactivity, or a 'flaccid' bladder should not be included.
    4. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative (or representatives, as per local regulatory and legal requirements) has been informed of all pertinent aspects of the study. In addition, an assent from the subject will be obtained when appropriate, and when the potential subject is capable of providing assent.
    5. Female subjects who are of child-bearing potential (defined as ?9 years old or have experienced menarche, whichever is earlier) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
    a. Subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization.
    b. Subjects of child-bearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
    c. Sexually active male subjects must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
    6. Subjects must already have the ability to swallow tablets whole, without chewing or crushing. The first dose of medication will be given in clinic under observation, and any subject not able to swallow tablets will be excluded from the study.
    7. Subjects, and their legally acceptable representative(s), who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    Un miembro debidamente cualificado del equipo del estudio del investigador deberá analizar y documentar la elegibilidad de los sujetos antes de su inclusión en el estudio.
    Los sujetos deberán cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:
    1. Sujetos de ambos sexos, de 6 a 16 años y 11 meses (edad en el momento de la primera dosis), es decir, que hayan cumplido 6 años pero no 17.
    2. Peso corporal total mayor de 25 kg.
    3. Sujetos con una enfermedad neurológica estable e HND clínica o urodinámicamente demostrada, confirmada urodinámicamente en la visita 2 mediante hiperactividad del detrusor o disminución de la distensibilidad vesical, con disminución de la capacidad vesical cistométrica máxima.
    NOTA: No podrán participar los sujetos con vejiga hipocontráctil, hipoactividad del detrusor o vejiga ?flácida?.
    4. Existencia de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al sujeto (o a su representante legal) de todos los aspectos pertinentes del estudio. Además, se obtendrá el asentimiento del sujeto cuando proceda, siempre que el posible participante sea capaz de otorgarlo.
    5. Las mujeres que estén en edad fértil (definidas como aquellas con una edad ?9 años o que hayan experimentado la menarquia, lo que ocurra antes) no deben tener intención de quedarse embarazadas, estar embarazadas ni ser lactantes. Se aplicarán las condiciones siguientes:
    a. Las mujeres en edad fértil deberán tener un resultado negativo confirmado en una prueba de embarazo efectuada antes de la aleatorización.
    b. Las mujeres en edad fértil deberán comprometerse a utilizar un método anticonceptivo eficaz durante el periodo del ensayo y hasta al menos 28 días después de finalizar el tratamiento. Entre los métodos anticonceptivos eficaces figura la abstinencia.
    c. Los varones sexualmente activos deberán comprometerse a utilizar un método anticonceptivo eficaz durante el periodo del ensayo y hasta al menos 28 días después de finalizar el tratamiento.
    En la sección 4.4 se recogen más detalles de la definición de edad fértil y métodos anticonceptivos eficaces.
    1. Los sujetos ya deben tener la capacidad de tragar comprimidos enteros, sin masticarlos ni romperlos. La primera dosis de medicación se administrará en el centro bajo observación y se excluirá del estudio a todo sujeto que no sea capaz de tragar comprimidos.
    2. Los sujetos y sus cuidadores o padres se muestran dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio, y son capaces de hacerlo.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Any condition known to affect drug absorption (eg, gastrectomy).
    2. History of surgical procedures that could confound study results or increase the risk to subjects, including but not limited to: sphincterotomy, artificial sphincter, implantable stent, bladder augmentation procedures, urinary diversion procedures. Continent diversion procedures eg, Mitrofanoff are permitted.
    3. A history of indwelling urinary catheter within 4 weeks of participation in this study. Intermittent catheterization is permitted.
    4. Any comorbid condition that, in the opinion of the investigator, would confound study results or increase the risk to subjects eg, current history of bladder calculus.
    5. A history of autonomic dysreflexia eg, increased blood pressure with bladder filling or other stimuli.
    6. Subjects with clinically relevant out-of-range values for hematology or serum chemistry as confirmed by blood tests performed at Visit 1, and which require the subject?s exclusion in the opinion of the investigator.
    7. A 12-lead ECG at screening with clinically significant abnormality.
    8. Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
    9. Subjects required to take or expected to initiate concomitant medications that can interact with the pharmacokinetics and/or pharmacodynamics of fesoterodine or oxybutynin, such as:
    ? Potent CYP3A4 inhibitors within 3 weeks prior to Visit 2 (baseline), or the expectation to start such a treatment during the trial. ? Medications capable of inducing CYP3A4 enzyme metabolism. ? Drugs for the treatment of overactive bladder (eg, darifenacin, oxybutynin (including intravesical), propiverine, tolterodine, fesoterodine, solifenacin and trospium). ? Treatment with botulinum toxin A within 9 months prior to Visit 2 (baseline). ? Drugs with antispasmodic, parasympathetic, or cholinergic effects. Stable use of desmopressin for enuresis is allowed if established for at least 3 months.
    Previous treatment with these medications does not exclude subjects. However, prohibited concomitant medications must have a minimum washout appropriate to the drug so any clinical effect is at a minimum prior to beginning the bladder diary, and baseline urodynamic evaluations.
    10. Intermittent or unstable use of diuretics or alpha blockers, tricyclic antidepressants or any other treatment that may confound the results of the study, within 2 weeks or an appropriate washout period (whichever is longer) prior to starting the bladder diary or during the course of the study. Stable usage/dosage is allowed if established for at least 3 months.
    11. Electrostimulation therapy or bladder retraining if started within 30 days of Visit 1 or are expected to start such therapy during the study period. Subjects who are on an established regimen may remain on this for the duration of the study.
    12. Subjects with a clinically significant urinary tract infection (UTI) at screening.
    Urine microscopy, culture and sensitivity testing will be performed in the event of:
    ? presence of symptoms (eg, fever, flank pain), or ? positive leucocytes and/or nitrites on urinalysis, or ? if subject has a documented history of vesicoureteral reflux (VUR).
    A clinically significant UTI is defined as:
    ? positive urine culture with a uropathogen and the presence of symptoms, or ? pyuria and the presence of symptoms, or ? positive urine culture with a uropathogen with or without symptoms in a subject with a documented history of VUR.
    Subjects who are found to have an active UTI during screening may continue screening activities on resolution of symptoms or treatment of the UTI to the satisfaction of the treating physician.
    13. Subjects not requiring intermittent catheterization who have a post-void residual volume greater than 20 ml as determined by transabdominal ultrasound (eg, bladder scan) immediately after urination. If at screening, the PVR is found to be greater than 20 ml the subject will be asked to void again. Repeat PVR assessment should be made as soon as possible, and no more than 5 minutes, after the second void. Subjects found to have a persistently elevated PVR >20 ml at this visit will be excluded from the study.
    14. Subjects with any history of malignancy.
    For the remaining exclusion criteria please refer to the Protocol.
    1. Cualquier trastorno que afecte a la absorción de los fármacos.
    2. Antecedentes de intervenciones quirúrgicas que puedan confundir los resultados del estudio o aumentar el riesgo para los sujetos. Se permiten los procedimientos de derivación continente, por ejemplo, el de Mitrofanoff.
    3. Antecedentes de sondaje urinario permanente en las 4 semanas anteriores a la participación en este estudio. Se permite el sondaje intermitente.
    4. Cualquier enfermedad concomitante que, en opinión del investigador, pueda confundir los resultados del estudio o aumentar el riesgo para los sujetos.
    5. Antecedentes de disreflexia autónoma.
    6. Sujetos con valores de hematología o bioquímica sérica situados fuera del intervalo de referencia y clínicamente relevantes, confirmados mediante análisis de sangre realizados en la visita 1, y que, en opinión del investigador, requieran la exclusión del sujeto.
    7. ECG de 12 derivaciones en la visita de selección que muestre anomalías de importancia clínica.
    9. Sujetos que precisen tomar o prevean empezar a recibir medicamentos concomitantes que puedan interaccionar con la farmacocinética o farmacodinamia de fesoterodina u oxibutinina.
    10. Uso intermitente o inestable de diuréticos o alfabloqueantes, antidepresivos tricíclicos o cualquier otro tratamiento que pueda confundir los resultados del estudio, en las 2 semanas o un periodo de lavado apropiado (lo que suponga más tiempo) antes del inicio del diario miccional o durante el estudio. Se permite el uso o una posología estable si se mantiene desde 3 meses antes, como mínimo.
    11. Electroestimulación o reeducación vesical si se inicia en los 30 días previos a la visita 1 o se prevé empezar dicho tratamiento durante el periodo del estudio. Los sujetos que estén recibiendo una pauta establecida podrán seguir con ella durante el estudio.
    12. Sujetos con una infección urinaria (IU) de importancia clínica en la selección.
    13. Sujetos que no precisen sondaje intermitente y que presenten un volumen de orina residual posmiccional superior a 20 ml, determinado mediante ecografía transabdominal (por ejemplo, ecografía de la vejiga) inmediatamente después de la micción. Si, en la selección, el VORP es superior a 20 ml, se pedirá al sujeto que vuelva a orinar.
    14. Sujetos con antecedentes de neoplasias malignas.
    15. Sujetos con cualquier trastorno o riesgo de cualquier trastorno que contraindique el uso de fesoterodina u oxibutinina o que justifique la adopción de precauciones relativas a su uso, como:
    ? Hipersensibilidad a fesoterodina, tolterodina u oxibutinina.
    ? Antecedentes conocidos de hipersensibilidad al cacahuete o a la soja o a cualquiera de los excipientes de la formulación de fesoterodina o de oxibutinina.
    ? Retención gástrica.
    ? Reducción importante de la motilidad gastrointestinal (sin tratamiento activo).
    ? Glaucoma de ángulo estrecho no controlado.
    ? Trastornos obstructivos del aparato digestivo.
    ? Miastenia grave.
    ? Insuficiencia hepática grave (clase C de Child-Pugh).
    ? Colitis ulcerosa grave.
    ? Megacolon tóxico.
    16. Sujetos que han recibido cualquier fármaco en investigación en las 4 semanas, o el equivalente a 5 semividas (lo que suponga más tiempo), anteriores a la visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Maximum cystometric bladder capacity defined as maximal tolerable cystometric capacity or until voiding/leaking begins or at 40 cm H2O.
    Capacidad vesical cistométrica máxima, definida como la capacidad cistométrica máxima tolerable o hasta que empiece la micción/fuga o se alcancen 40 cm H2O.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum cystometric bladder capacity (urodynamics) - Visits 2 & 5
    Capacidad vesical cistométrica maxima - visitas 2 y 5
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    ? Detrusor pressure at maximum bladder capacity.
    ? Presence of involuntary detrusor contractions (IDC).
    ? Bladder volume at first IDC.
    ? Bladder compliance.
    ? Mean number of micturitions and/or catheterizations/24 hrs.
    ? Mean number of incontinence episodes/24 hrs.
    ? Mean urgency episodes/24 hrs if applicable (only for sensate subjects).
    ? Mean volume voided per micturition or mean volume per catheterization.
    Safety Endpoints
    ? Adverse events, including monitoring of targeted events including, but not limited to:
    ? Anticholinergic effects such as dry mouth, dry eyes and constipation.
    ? CNS effects such as behavioral changes (eg, aggression), decreased cognitive function, headache, seizures, somnolence.
    ? Visual effects such as accommodation disorder, blurred vision, and amblyopia.
    ? Visual acuity and accommodation tests.
    ? Cognitive function by the Child Behavior CheckList and Grooved Pegboard Test.
    ? Vital Signs, including heart rate in the context of age-appropriate norms.
    ? Urinary Tract Infection, as evidenced by urinalysis, urine microscopy, culture and sensitivity.
    ? Clinical Laboratory Evaluations in the context of age-appropriate norms, with particular reference to liver function tests and renal chemistry.
    ? Post-void residual volume (PVR) in subjects not performing CIC, or with >1 urinary tract infection (UTI) during the study.
    Pharmacokinetic Endpoints
    ? Model-based pharmacokinetic parameter estimates for absorption rate constant (Ka), apparent oral clearance (CL/F) and volumes of distribution (Vd) to predict the area under the curve (AUC), maximum concentration (Cmax), time to reach Cmax (Tmax) and half-life of 5-HMT.
    Criterios de valoración de la eficacia:
    ? Presión del detrusor en el momento de capacidad vesical máxima.
    ? Presencia de contracciones involuntarias del detrusor (CID).
    ? Volumen vesical con la primera CID.
    ? Distensibilidad vesical.
    ? Número medio de micciones o sondajes/24 h.
    ? Número medio de episodios de incontinencia/24 h.
    ? Número medio de episodios de urgencia/24 h, si procede (solo en los sujetos sensibles).
    ? Volumen medio expulsado por micción o volumen medio por sondaje.
    Criterios de valoración de la seguridad:
    ? Acontecimientos adversos, incluida la vigilancia de acontecimientos de interés, entre otros:
    ? Efectos anticolinérgicos, como sequedad de boca, sequedad ocular y estreñimiento.
    ? Efectos sobre el SNC, como alteraciones del comportamiento (por ejemplo, agresividad), reducción de la función cognitiva, cefalea, crisis epilépticas y somnolencia.
    ? Efectos visuales, como trastornos de la acomodación, visión borrosa y ambliopía.
    ? Pruebas de agudeza y acomodación visual.
    ? Función cognitiva según el inventario del comportamiento de niños (CBCL) y la prueba del tablero de clavijas con ranuras.
    ? Constantes vitales, entre ellas, frecuencia cardiaca en el contexto de normas apropiadas para la edad.
    ? Infección urinaria, según lo evidenciado por el análisis de orina, examen microscópico de orina, cultivo y antibiograma.
    ? Evaluaciones analíticas en el contexto de normas apropiadas para la edad, con referencia especial a las pruebas de función hepática y la bioquímica renal.
    ? Volumen de orina residual posmiccional (VORP) en sujetos que no practiquen SIL o que presenten más de una infección urinaria (IU) durante el estudio.
    Criterios de valoración farmacocinéticos:
    ? Estimaciones de parámetros farmacocinéticos basadas en modelos para la constante de la velocidad de absorción (Ka), el aclaramiento oral aparente (CL/F) y los volúmenes de distribución (Vd) a fin de predecir el área bajo la curva (AUC), la concentración máxima (Cmáx), el tiempo hasta alcanzar la Cmáx (Tmáx) y la semivida de 5-HMT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Urodynamic endpoints at Visits 2 & 5
    ediary endpoints = Visits 2 & 5
    Vital Signs, including heart rate.= Visits 1, 2, 3, 5 & 7
    Adverse events = Visits 2, 3 , 4, 5, 6, 7 & 8 (Also, weeks 1, 2 & 3 for oxybutynin subjects)
    Clinical Laboratory Evaluations =Visits 1, 2, 3, 5, & 7
    Post-void residual volume (PVR) in subjects not performing CIC, or with >1 urinary tract
    infection (UTI) during the study= Visits 1, 2 ,3, 5 & 7
    Pharmacokinetic Endpoints = Visit 5 ( 3 samples)
    Criterios de valoración urodinámicos en Visitas 2 y 5
    Criterios de valoración del diario electrónico en Visitas 2 y 5
    Constantes vitales, entre ellas, frecuencia cardiaca en Visitas 1, 2, 3, 5 y 7
    Acontecimientos adversos en Visitas 2, 3 , 4, 5, 6, 7 y 8 (también, semanas 1, 2 y 3 para sujetos con oxibutinina)
    Evaluaciones analíticas en Visits 1, 2, 3, 5, y 7
    Volumen de orina residual posmiccional (PORP) en sujetos que no practiquen SIL , o que presenten más de una infección urinaria (IU) durante el estudio en Visitas 1, 2 ,3, 5 y 7
    Criterios de valoración farmaconinéticos en Visita 5 ( 3 extracciones)
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Tolerabilidad
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    safety extension
    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.8.2.4Number of treatment arms in the trial3
    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 EEA46
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Chile
    Czech Republic
    Estonia
    Finland
    France
    Greece
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LSLV or the date upon which Pfizer receives notification by the External Data Monitoring Committee to terminate the study - as per protocol
    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 months5
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 88
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 44
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 44
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally acceptable reps must give informed consent prior to the start of the study. Consent should be obtained from both (if available) of the child?s legal representatives. In addition, the child?s assent must be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 132
    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)
    Subjects should continue with the local standard of care as applicable to the country.
    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 Decision2012-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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