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    Summary
    EudraCT Number:2010-023775-25
    Sponsor's Protocol Code Number:3652-CL-0019
    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:2011-06-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-023775-25
    A.3Full title of the trial
    A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of CP/CPPS
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, en grupos paralelos, con un diseño adaptativo combinando prueba de concepto y búsqueda de dosis para evaluar la eficacia, seguridad, farmacodinámica y farmacocinética de ASP3652 en el tratamiento de la prostatitis crónica/síndrome de dolor pélvico crónico
    A.3.2Name or abbreviated title of the trial where available
    AZURE
    A.4.1Sponsor's protocol code number3652-CL-0019
    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 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameASP3652
    D.3.2Product code ASP3652
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeASP3652
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameASP3652
    D.3.2Product code ASP3652
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeASP3652
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    prostatitis crónica/síndrome de dolor pélvico crónico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10064189
    E.1.2Term Chronic pelvic pain syndrome
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10009109
    E.1.2Term Chronic prostatitis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigar la eficacia de ASP3652 en los pacientes con prostatitis crónica/síndrome de dolor pélvico crónico (PC/SDPC), es decir, obtener una prueba de concepto
    E.2.2Secondary objectives of the trial
    Evaluar la dosis óptima de ASP3652 para el tratamiento de los pacientes con PC/SDPC.
    Investigar la seguridad y tolerabilidad de ASP3652 en los pacientes con PC/SDPC.
    Investigar la farmacocinética y farmacodinamia de ASP3652 en los pacientes con PC/SDPC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    En la selección, el paciente
    1. Ha firmado el consentimiento informado
    2. Es varón y tiene una edad mínima de 18 años
    3. Se le ha diagnosticado de PC/SDPC; es decir, dolor o molestias en la región pélvica durante al menos 3 meses en los 6 meses anteriores en ausencia de infección urinaria (IU) u otra causa pélvica/urológica
    4. Tiene una puntuación total NIH-CPSI de, como mínimo, 15
    5. Tiene una puntuación de 4 o más en la pregunta número 4 de la escala NIH-CPSI
    6. Refiere dolor a la palpación de la próstata o los tejidos circundantes/estructuras no prostáticas en el tacto rectal (TR) o dolor a la palpación del periné/región genital
    7. Respuesta Sí a al menos 1 de los 6 apartados de las preguntas combinadas 1 y 2 de la escala NIH-CPSI
    8. Se muestra dispuesto y es capaz de cumplir los requisitos del estudio (por ejemplo, realizar anotaciones en el diario miccional) y de acudir a todas las visitas del estudio exigidas.

    En la aleatorización se confirma que el paciente
    9. Tiene una puntuación total NIH-CPSI de, como mínimo, 15
    10. Tiene una puntuación de 4 o más en la pregunta número 4 de la escala NIH-CPSI

    11. Se muestra dispuesto y es capaz de cumplir los requisitos del estudio (por ejemplo, cumplimentar los cuestionarios y acudir a las visitas del estudio exigidas).
    E.4Principal exclusion criteria
    En la selección, el paciente NO debe presentar:
    1.Dolor testicular unilateral, peniano o escrotal aislado como síntoma solitario de dolor pélvico
    2.Infección urinaria (IU) o de la próstata identificada en la selección mediante el análisis fraccionado de la orina antes y después de un masaje prostático (prueba de 2 vasos, AADMP) o en los 3 meses anteriores a la selección. (Los pacientes diagnosticados de IU en el período de selección no podrán ser objeto de selección nuevamente)
    3.Cualquier intervención previa sobre la próstata o la vejiga (por ejemplo, dilatación con globo, tratamientos mínimamente invasores, microondas, termoterapia o cirugía), tratamiento intravesical (por ejemplo, quimioterapia o BCG), irradiación pélvica/abdominal o biopsia de próstata en los 3 meses anteriores a la selección
    4.Estenosis uretral sintomática*
    5.Cálculos vesicales o ureterales sintomáticos*
    6.Neoplasia maligna de las vías urinarias inferiores:(Micro)hematuria positiva en el sedimento PSA > 4 ng/ml o TR anómalo indicativo de tumor
    7.Obstrucción intensa de la salida de la vejiga (es decir, puntuación IPSS igual o mayor de 20 o en opinión del investigador)
    8.Vejiga hiperactiva (VHA) con incontinencia, diagnosticada antes de la visita de selección*
    9.Volumen residual posmiccional (VRPM) significativo, mayor de 150 ml
    10.Anomalías clínicamente significativas en la ecografía transabdominal de vejiga y próstata (por ejemplo, absceso prostático, masa vesical o divertículo vesical)
    11.Enfermedad o defecto neurológico que afecta a la función vesical (por ejemplo, vejiga neurógena, enfermedad neurológica sistémica o central, como esclerosis múltiple o enfermedad de Parkinson)*
    12.Enfermedad de transmisión sexual activa en la actualidad (como verrugas genitales, herpes genital y VIH/SIDA)*
    13.Abuso de sustancias (incluido alcohol) o cualquier uso de delta-9-tetrahidrocannabinol (THC) según lo evaluado en la selección mediante un análisis en orina positivo de THC
    14.Antecedentes o presencia de una enfermedad inflamatoria intestinal
    15.Fibromialgia intensa, síndrome de intestino irritable intenso o síndrome de fatiga crónica intenso*
    16.Estreñimiento o diarrea intensos, diverticulitis activa o hemorragia digestiva no investigada*
    17.Depresión mayor (es decir, puntuación de 27 o más en la Escala de depresión del Center for Epidemiological Studies (CES-D))
    18.Utilización de esteroides sistémicos, inmunomoduladores, anticonvulsivos, inhibidores del citocromo P4502C8 (CYP2C8), medicación a base de cannabis/THC, analgésicos opiáceos o antivirales/antibacterianos/antimicóticos (salvo tópicos) durante las 4 últimas semanas antes de la selección
    19.Inicio, suspensión o variación de la dosis de antidepresivos, alfabloqueantes, inhibidores de la 5-alfa reductasa, antimuscarínicos, benzodiazepinas, miorrelajantes, antiinflamatorios no esteroideos, analgésicos no opiáceos y tratamientos de fitoterapia durante las 4 últimas semanas antes de la selección. Los pacientes deben continuar con estos medicamentos en esa misma dosis estable durante todo el estudio
    20.Enfermedad hepática o biliar activa. La AST o la ALT no debe ser > 3 veces el límite superior de la normalidad (LSN). La bilirrubina total no debe ser > 2 veces el LSN
    21.Valores analíticos de seguridad en orina o sangre anómalos y clínicamente significativos
    22.Índice de masa corporal (IMC) de 40 kg/m2 o mayor (obesidad mórbida)
    23.Neoplasia maligna diagnosticada en los 5 años anteriores a la visita de selección, salvo un cáncer de piel no melanomatoso localizado y tratado con intención curativa (por ejemplo, carcinoma basocelular o espinocelular)*
    24.Enfermedad renal, hepática, respiratoria, hematológica, genitourinaria (salvo PC/SDPC), cardiovascular, endocrina (por ejemplo, neuropatía diabética), neurológica, psiquiátrica u otra afección médica clínicamente grave, inestable o incontrolada que, en opinión del investigador, podría poner en riesgo la seguridad del paciente o enmascarar las medidas de eficacia*
    25.Enfermedad psiquiátrica, incapacidad mental o barrera idiomática que, según el criterio del investigador, podría dificultar la participación del paciente en el ensayo*
    26.Participación en cualquier estudio clínico o tratamiento con cualquier medicamento o dispositivo en investigación en los 30 días o el período estipulado por las normativas locales, lo que sea más prolongado, antes de la selección (visita 1).
    E.5 End points
    E.5.1Primary end point(s)
    Variación con respecto al período basal de la puntuación total NIH-CPSI al cabo de 12 semanas de tratamiento (es decir, visita 6)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    establishment of proof of concept
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    adaptive design
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 350
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
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