Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-004138-12
    Sponsor's Protocol Code Number:6294-CL-0101
    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:2017-09-18
    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 number2016-004138-12
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis
    Estudio fase 2a, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, prueba de concepto para investigar la eficacia, la seguridad, la farmacodinámica y la farmacocinética de
    ASP6294 en el tratamiento de mujeres con síndrome de vejiga dolorosa/cistitis intersticial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.
    Estudio sobre el efecto de ASP6294 en el tratamiento de mujeres con síndrome de vejiga dolorosa/cistitis intersticial
    A.4.1Sponsor's protocol code number6294-CL-0101
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    B.5.6E-mailcontact@nl.astellas.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 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 nameASP6294
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeASP6294
    D.3.9.3Other descriptive nameASP6294
    D.3.9.4EV Substance CodeSUB170581
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)
    Síndrome de vejiga dolorosa/cistitis intersticial (SVD/CI)
    E.1.1.1Medical condition in easily understood language
    Bladder Pain Syndrome
    Síndrome de vejiga dolorosa
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071166
    E.1.2Term Bladder pain syndrome
    E.1.2System Organ Class 100000017419
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To investigate efficacy of ASP6294 in female subjects with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC).
    2. To investigate safety and tolerability of ASP6294 in female subjects with BPS/IC.
    3. To investigate the pharmacokinetics and pharmacodynamics of ASP6294 in female subjects with BPS/IC.
    1. Investigar la eficacia de ASP6294 en mujeres con síndrome de vejiga dolorosa/cistitis intersticial (SVD/CI).
    2. Investigar la seguridad y la tolerabilidad de ASP6294 en mujeres con SVD/CI.
    3. Investigar la farmacocinética y la farmacodinámica de ASP6294 en mujeres con SVD/CI.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening (Visit 1)
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is female and at least 18 years of age.
    3. The subject’s signs, symptoms and diagnostic work-up are in accordance with the ESSIC definition for BPS/IC: pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least 1 other urinary symptom such as persistent urge to void or frequency, for at least 6 months in absence of urinary infection or other obvious pathology or identifiable causes. There is documented proof of the diagnosis BPS/IC that has been entered into the subject’s records at least 2 months prior to Visit 1/Screening.
    4. Subject has a score of ≥ 4 and ≤ 9 for pain as assessed by scoring the average pain of the week preceding Visit 1/Screening, using an 11-point NRS (0-10).
    5. Subject has an estimated voiding frequency of ≥ 8 and ≤ 30 voids per 24 hours.
    6. Subject has a score of ≥ 7 on the ICSI questionnaire.
    7. The subject must either:
    Be of nonchildbearing potential:
    - Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
    - Documented surgically sterile
    Or, if of childbearing potential,
    - Agree not to try to become pregnant during the study and for 5 half-lives after the final study drug administration at Visit 5/Week 8, and
    - Have a negative urine pregnancy test at Visit 1/Screening, and
    - If heterosexually active, agree to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 5 half-lives after the final study drug administration at Visit 5/Week 8. Highly effective birth control methods include established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device or intrauterine system.
    8. Subjects must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
    9. Subject must agree not to donate ova starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
    10. Subject must be willing and able to comply with study requirements.
    11. Subject agrees not to participate in another interventional study while participating in the present study.
    12. The subject has undergone at least two different therapies for BPS/IC with unsatisfactory results, prior to study entry.
    At randomization:
    13. Subject has at least moderate pain as reflected by an average MDP of ≥ 4.0 and ≤ 9.0. The average MDP is the average of daily assessments of MDP in the week prior to the visit with at least 5 recordings. Additionally, the MDP recordings must not differ over 4 points between consecutive days.
    14. Subject has a mean voiding frequency of ≥ 8.0 and ≤ 30.0 per 24 hours as assessed with the 3 day electronic micturition diary in the week prior to the visit.
    15. Subject is confirmed to be willing to comply and has shown to be compliant with all study requirements during the run-in period.
    En la visita de selección (visita 1)
    1. Obtención del consentimiento informado y la declaración relativa a privacidad aprobados por el Comité de Ética de la Investigación con medicamentos (CEIm), de conformidad con las normativas nacionales, de la paciente antes de realizar ningún procedimiento relacionado con el estudio (incluida la retirada de la medicación prohibida, si procede).
    2. Es mujer y tiene una edad mínima de 18 años.
    3. Los signos, síntomas y estudios diagnósticos de la paciente se ajustan a la definición de SVD/CI de la ESSIC: dolor, presión o molestias pélvicas que se perciben como relacionados con la vejiga, acompañados de al menos otro síntoma urinario, como deseo persistente de orinar o polaquiuria, durante un mínimo de seis meses en ausencia de infección urinaria u otra enfermedad evidente o causas identificables [Van de Merwe, 2008].
    Existen pruebas documentadas del diagnóstico de SVD/CI que se han introducido en la historia clínica de la paciente al menos dos meses antes de la visita 1/selección.
    4. La paciente tiene una puntuación ≥ 4 y ≤ 9 de dolor al evaluar el dolor promedio en la semana previa a la visita 1/selección mediante una EVN de 11 puntos (0-10).
    5. La paciente presenta una frecuencia miccional ≥ 8 y ≤ 30 micciones cada 24 horas.
    6. La paciente tiene una puntuación ≥ 7 en el cuestionario ICSI.
    7. La paciente debe:
    - No estar en edad fértil:
    o Situación posmenopáusica (mínimo de un año sin menstruación sin que exista otra causa patológica o fisiológica evidente) antes de la selección, o
    o Esterilización quirúrgica documentada (por ejemplo, histerectomía, salpingectomía bilateral u ovariectomía bilateral).
    - O, en caso de estar en edad fértil:
    o Comprometerse a no intentar quedarse embarazada durante el estudio ni durante el equivalente a cinco semividas (es decir, 70 días) tras la última administración del fármaco del estudio en la visita 5/semana 8, y
    o Dar negativo en una prueba de embarazo en orina realizada en la visita 1/selección, yEn caso de mantener relaciones heterosexuales, comprometerse a utilizar de forma sistemática un método anticonceptivo muy eficaz a partir de la selección, durante todo el período del estudio y durante el equivalente a cinco semividas (es decir, 70 días) tras la última administración del fármaco del estudio en la visita 5/semana 8. Se consideran métodos anticonceptivos muy eficaces el uso consolidado de métodos anticonceptivos orales, inyectables o implantados O la colocación de un dispositivo o sistema intrauterino.
    8. La paciente debe comprometerse a no amamantar a partir de la selección, durante todo el período del estudio y durante el equivalente a cinco semividas (es decir, 70 días) tras la última administración del fármaco del estudio en la visita 5/semana 8.
    9. La paciente debe comprometerse a no donar óvulos a partir de la selección, durante todo el período del estudio y durante el equivalente a cinco semividas (es decir, 70 días) tras la última administración del fármaco del estudio en la visita 5/semana 8.
    10. La paciente debe estar dispuesta y ser capaz de cumplir los requisitos del estudio.
    11. La paciente se compromete a no participar en otro estudio de intervención durante su participación en este estudio.
    12. La paciente se ha sometido sin éxito a un mínimo de 2 tratamientos diferentes para SVD/CI antes de su incorporación al estudio.
    En la aleatorización (visita 2/basal):
    13. La paciente presenta dolor moderado, como mínimo, según un DDM promedio ≥ 4,0 y ≤ 9,0. El DDM promedio es el promedio de las evaluaciones diarias de DDM en la semana previa a la visita, con un mínimo de 5 registros. Además, los registros de DDM no podrán diferir en más de 4 puntos entre días consecutivos.
    14. La paciente tiene una frecuencia miccional media ≥ 8,0 y ≤ 30,0 cada 24 horas, evaluada con el diario electrónico de micciones de tres días en la semana previa a la visita.
    15. La paciente confirma que está dispuesta a cumplir y se ha demostrado su cumplimiento de todos los requisitos del estudio durante el período de preinclusión.
    E.4Principal exclusion criteria
    1.Subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
    2.Subject has a score of ≥ 30 on the Pain Catastrophizing Scale.
    3.Subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
    4.Subject has significant pelvic floor pain or spasm which is considered the main cause of the chronic pelvic/bladder pain as concluded by the investigator based on the pelvic floor examination.
    5.Subject has undergone a fulguration or excision of a Hunner’s lesion any time prior to the screening visit.
    6.Subject has recently undergone or started treatment for BPS/IC as specified below:
    -subject has undergone a cystoscopy with hydrodistension or Botox injections in the bladder within 6 months prior to the screening visit.
    -subject has received non-pharmacological interventions for BPS/IC (including but not limited to electric stimulation therapy or acupuncture therapy) within 3 months prior to the screening visit.
    -subject has received any intravesical pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide) within 4 weeks prior to the screening visit
    -subject had an initiation, discontinuation, or variation in the dose and/or frequency of antimuscarinics, mirabegron, antidepressants (including amitriptyline), anticonvulsants, benzodiazepines, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs, non opioid analgesics, pentosan polysulphate sodium, homeopathic medication and/or herbal therapies during the last 4 weeks prior to the screening visit.
    -subject has had changes in non-pharmacological treatment for BPS/IC during the last 4 weeks prior to the screening visit.
    7.Subject has bladder pathology as:
    -post-void residual (PVR) >200 mL.
    -known currently symptomatic urethral diverticulum.
    -genital tract condition or pelvic pathology that may complicate diagnosis and the evaluation of pelvic pain and urinary symptoms.
    -known currently symptomatic bladder or ureteral calculi.
    -subject currently has cystitis or has had a documented symptomatic bacterial cystitis within the last 1 month prior to the screening visit. In case of bacterial cystitis (UTI), the subject can be re-screened 1 month after successful treatment.
    -subject has currently clinically significant urinary bladder abnormalities except for abnormalities associated with BPS/IC.
    -subject has had any invasive procedures of either the urinary bladder, urethra, ureter or renal pelvis within 3 months prior to the screening visit.
    -subject has a known current neurologic disease or a defect affecting urinary bladder function.
    -subject has a known current lower urinary tract malignancy.
    8.Subject has a known history of, or currently has inflammatory bowel disease and/or Sjögren Syndrome.
    9.Subject has a known current severe constipation and/or severe diarrhea, severe active diverticulitis and/or severe gastrointestinal bleeding.
    10.Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
    11.Subject has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
    12.Subject has a known history of an allergic or anaphylactic reaction to biological drugs.
    13.Subject has received a biological drug during the last 6 months prior to the screening visit.
    14.Subject has a known history of hepatitis B or, C or of human immunodeficiency virus (HIV) infection.
    15.Subject has a known history of or has a currently active or treated sexually transmittable disease.
    17.Subject has peripheral neuropathy, or an abnormality has been observed during the sensory testing at Visit 1/Screening.
    18.Subject has a known currently clinically severe, unstable or uncontrolled renal, hepatic, respiratory, hematological, genitourinary (except BPS/IC), cardiovascular, endocrine, neurological, psychiatric, or other medical illness that, in the opinion of the investigator, may put the subject at safety risk or may mask measures of efficacy.
    19.Subject has had any malignancy diagnosed within 5 years prior to the screening visit, except for curative treated localized non-melanoma skin cancer.
    21.Subject has a body mass index of ≥ 40 kg/m2 as sign of morbid obesity.
    23.Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to the screening visit.
    25.Results of the Visit 1/Screening blood sample indicate that the subject has active hepatic and/or biliary disease, defined as: liver enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN), or total bilirubin (TBL) > 1.5 times the ULN.
    27.Results of the Visit 1/Screening blood/urine samples indicate that the subject has clinically significant abnormal biochemistry, hematology or urinalysis safety laboratory values other than those mentioned under item 25, as judged by the investigator.
    1.La paciente (pte.) presenta artrosis o tiene antecedentes de artrosis rápidamente progresiva.
    2.La pte.tiene una puntuación ≥ 30 en la escala PCS.
    3.La pte.tiene una puntuación > 12 en la escala HADS-D.
    4.La pte.presenta dolor o espasmo significativo del suelo de la pelvis que se considera la causa principal del dolor pélvico/vesical crónico, según la conclusión del investigador basada en la exploración del suelo de la pelvis.
    5.La pte.se ha sometido a una fulguración o escisión de una lesión de Hunner en cualquier momento antes de la visita de selección(VS).
    6.La pte.se ha sometido o ha comenzado recientemente el tratamiento para el SVD/CI según se indica a continuación:
    •Se ha sometido a una cistoscopia con hidrodistensión o a inyecciones de toxina botulínica en la vejiga en los seis meses previos a la VS.
    -Ha recibido intervenciones no farmacológicas para el SVD/CI (ej.terapia de estimulación eléctrica o acupuntura) en los tres meses previos a la VS.
    •Ha recibido cualquier tratamiento farmacológico intravesical para el SVD/CI (ej.heparina o dimetilsulfóxido) en las cuatro semanas previas a la VS.
    •Ha empezado, suspendido o modificado la dosis o la frecuencia de administración de antimuscarínicos, mirabegrón, antidepresivos (como amitriptilina), antiepilépticos, benzodiacepinas, miorrelajantes, antiinflamatorios no esteroideos, analgésicos no opiáceos, polisulfato sódico de pentosano, medicación homeopática o fitoterapia en las cuatro semanas previas a la VS.
    •Se ha sometido a modificaciones del tratamiento no farmacológico para el SVD/CI (ej, dieta o fisioterapia) en las cuatro semanas previas a la VS.
    7.La pte.presenta una enfermedad vesical, según se indica a continuación:
    •Presencia de un residuo posmiccional (RPM) > 200 ml.
    •Presencia activa de un divertículo uretral sintomático.
    •Presencia de una enfermedad del aparato genital o un trastorno pélvico que podría complicar el diagnóstico y la evaluación del dolor pélvico y los síntomas urinarios.
    •Presencia de cálculos vesicales o ureterales sintomáticos.
    •Presencia de cistitis o existencia de una cistitis bacteriana sintomática documentada en el mes previo a la VS. En caso de cistitis bacteriana (infección urinaria), la pte.podrá someterse a un nuevo proceso de selección 1 mes después de un tratamiento satisfactorio.
    •Presencia de anomalías vesicales clínicamente significativas, excepto anomalías relacionadas con el SVD/CI*.
    •Realización de cualquier procedimiento invasivo sobre la vejiga, uretra, uréter o pelvis renal en los 3 meses previos a la VS.
    •Presencia activa de una enfermedad neurológica o un defecto que afecta a la función vesical.
    •Presencia de una neoplasia maligna de las vías urinarias inferiores.
    8.Antecedentes conocidos o presencia de una enfermedad inflamatoria intestinal o síndrome de Sjögren.
    9.Presencia de estreñimiento o diarrea intensos, diverticulitis activa grave o hemorragia digestiva grave.
    10.Hipersensibilidad confirmada o supuesta a ASP6294 o a algún componente de la formulación utilizada.
    11.Embarazo en los 6 meses previos a la evaluación de selección o lactancia materna en los 3 meses previos a la selección.
    12.Antecedentes de reacción alérgica o anafiláctica a fármacos biológicos.
    13.Recepción de un fármaco biológico en los 6 meses previos a la VS.
    14.Antecedentes de hepatitis B o C o infección por el VIH.
    15.Antecedentes o presencia de una enfermedad de transmisión sexual activa o tratada.
    17.Presencia de neuropatía periférica u observación de una anomalía durante las pruebas sensitivas realizadas en la visita 1/selección.
    18.Presencia de una enfermedad renal, hepática, respiratoria, hematológica, genitourinaria(excepto SVD/CI),cardiovascular, endocrina,neurológica,psiquiátrica o de otro tipo clínicamente grave,inestable o incontrolada que, en opinión del investigador, podría suponer un riesgo para la seguridad de la pte.o enmascarar las determinaciones de eficacia.
    19.Diagnóstico de una neoplasia maligna en los 5 años previos a la VS, excepto cáncer de piel distinto del melanoma localizado y tratado con intención curativa.
    21.Índice de masa corporal ≥ 40 kg/m2 como signo de obesidad mórbida.
    23.Recepción de un tratamiento en investigación en los 28 días o el equivalente a 5 semividas, lo que suponga más tiempo, previos a la VS.
    25.Los resultados de la muestra de sangre de la visita 1/selección indican que la pte.presenta una enfermedad hepática o biliar activa, definida como: concentraciones de las enzimas hepáticas aspartato aminotransferasa(AST)o alanina aminotransferasa(ALT)> 2 veces el límite superior de la normalidad(LSN)o de bilirrubina total(BT)> 1,5 veces el LSN.
    27.Los resultados de las muestras de sangre/orina de la visita 1/selección indican que la pte.tiene unos valores analíticos de seguridad(bioquímica,hematología o análisis de orina)anómalos y clínicamente significativos distintos de los mencionados en el punto 25, según criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy
    Change from baseline in average MDP at Visit 6/Week 12.
    Criterio de valoración principal de la eficacia
    Variación del DDM promedio entre el momento basal y la visita 6/semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 6/Week 12
    Visita 6/semana 12
    E.5.2Secondary end point(s)
    Secondary efficacy
    - Change from baseline in average WDP at Visit 6/Week 12.
    - Change from baseline in mean voiding frequency at Visit 6/Week 12.
    - Change from baseline in mean number of level 3 or 4 urgency episodes (using the Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24 hours as assessed with the 3 day electronic micturition diary within the week preceding the study visit, at Visit 6/Week 12.
    - Assessment of the Global Response Assessment (GRA) at Visit 6/Week 12.
    - Change from baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) at Visit 6/Week 12.

    Safety
    - Frequency, nature and severity of Adverse Events (AEs).
    - Laboratory tests: standard hematology, biochemistry, urinalysis, urine culture (if indicated).
    - 12-lead ECG, vital signs measurements, sensory testing and physical examination.

    Pharmacokinetic and Pharmacodynamic
    - Pharmacokinetic: serum level of ASP6294 at all visits.
    - Pharmacodynamic: serum level of total NGF (and possibly other biomarkers) at all visits.

    Other
    - Presence and characteristics of anti-ASP6294 antibodies (ADA) at all visits.
    Criterios de valoración secundarios de la eficacia
    - Variación del PDD promedio entre el momento basal y la visita 6/semana 12.
    - Variación de la frecuencia miccional media entre el momento basal y la visita 6/semana 12.
    - Variación del número medio de episodios de tenesmo vesical de nivel 3 o 4 (utilizando la escala PPIUS [Escala de percepción por el paciente de la intensidad del tenesmo vesical]) cada 24 horas evaluada con el diario electrónico de micciones de tres días de la semana previa a la visita del estudio entre el momento basal y la visita 6/semana 12.
    - Evaluación de la respuesta global (GRA) en la visita 6/semana 12.
    - Variación de la puntuación BPIC-SS (Puntuación de síntomas de vejiga dolorosa/cistitis intersticial) entre el momento basal y la visita 6/semana 12.

    Seguridad
    •Frecuencia, naturaleza e intensidad de los acontecimientos adversos (AA).
    •Pruebas analíticas: determinaciones convencionales de hematología, bioquímica y análisis de orina y urocultivo (si está indicado).
    •ECG de 12 derivaciones, determinaciones de constantes vitales, pruebas sensitivas y exploración física.

    Farmacocinética y farmacodinámica
    •Farmacocinética: concentración sérica de ASP6294 en todas las visitas.
    •Farmacodinámica: concentración sérica de NGF total (y posiblemente otros biomarcadores) en todas las visitas.

    Otros
    •Presencia y características de los anticuerpos anti-ASP6294 (anticuerpos contra el fármaco (ACF)) en todas las visitas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 6/Week 12
    Visita 6/semana 12
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - Presence of anti-ASP6294 antibodies (ADA) at Visit 2/Baseline through Visit 7/Week 18.
    •Presencia de los anticuerpos anti-ASP6294 (anticuerpos contra el fármaco (ACF)) en la visita 2/basal hasta la visita 7/semana 18.
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Czech Republic
    Germany
    Hungary
    Latvia
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    The end of the study is defined as the last visit or follow-up contact of the last subject in the study.
    El final de estudio se define como la última visita o contacto de seguimiento del último paciente en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 131
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 163
    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)
    Not applicable.
    No aplica.
    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 Decision2017-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-21
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA