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   36111   clinical trials with a EudraCT protocol, of which   5936   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).
     
    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:2011-004555-39
    Sponsor's Protocol Code Number:3652-CL-0018
    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:2012-03-06
    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 number2011-004555-39
    A.3Full title of the trial
    A Phase 2, 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 female subjects with Bladder Pain Syndrome / Interstitial Cystitis
    Ensayo de fase II de doble-ciego, aleatorizado y controlado por placebo, de diseño adaptativo, con grupos paralelos, combinando prueba de concepto y búsqueda de dosis para investigar la eficacia, seguridad, farmacodinámica y farmacocinética del ASP3652 en el tratamiento de mujeres con síndrome de dolor vesical/cistitis intersticial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial Cystitis
    Ensayo aleatorizado comparando placebo y ASP3652 en el tratamiento de mujeres con Sindrome de Dolor Vesical/ Cistitis intersticial
    A.3.2Name or abbreviated title of the trial where available
    AMARANTH
    A.4.1Sponsor's protocol code number3652-CL-0018
    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
    B.5.3 Address:
    B.5.3.1Street AddressElisabethhof 19
    B.5.3.2Town/ cityLeiderdorp
    B.5.3.3Post code2353 EW
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455878
    B.5.5Fax number0031715455224
    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 nameASP3652
    D.3.2Product code ASP3652
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeASP3652
    D.3.9.3Other descriptive nameASP3652
    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) 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 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 No
    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.3.9.3Other descriptive nameASP3652
    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) 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 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
    Bladder Pain Syndrome / Interstitial Cystitis
    Síndrome de Dolor Vesical/Cistitis Intersticial
    E.1.1.1Medical condition in easily understood language
    Chronic pain in bladder and pelvic area
    Dolor crónico en la vejiga y área pélvica
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011796
    E.1.2Term Cystitis interstitial
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008927
    E.1.2Term Chronic interstitial cystitis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008928
    E.1.2Term Chronic interstitial cystitis NOS
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10071166
    E.1.2Term Bladder pain syndrome
    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 investigate efficacy of ASP3652 in female subjects with BPS/IC
    Investigar la eficacia del ASP3652 en mujeres con SDV/CI
    E.2.2Secondary objectives of the trial
    To assess the optimal dose of ASP3652 for the treatment of female subjects with BPS/IC.
    To investigate safety and tolerability of ASP3652 in female subjects with BPS/IC.
    To investigate the PK and PD of ASP3652 in female subjects with BPS/IC.
    Evaluar la dosis óptima del ASP3652 para el tratamiento de mujeres con SDV/CI.
    Investigar la seguridad y la tolerabilidad del ASP3652 en mujeres que padecen SDV/CI.
    Investigar la farmacocinética (FC) y farmacodinámica (FD) del ASP3652 en mujeres con SDV/CI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1:
    1. Written informed consent has been obtained. 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 or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Is female, 18 years of age or older and of Caucasian (white) ethnic background.
    3. Has previously been diagnosed with BPS/IC; i.e, pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes.
    4. Has a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F GUPI.
    5. Must practice a highly reliable method of birth control. When of childbearing potential, subjects must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs), sexual abstinence or vasectomized partner.
    6. Is willing and able to comply with study requirements (e.g, complete questionnaires and diaries) and attend all required study visits.

    At randomization (Visit 2/BV), the subject
    7. Is confirmed to have at least moderate pain as reflected by a MDP of at least 4.0. The MDP is the mean of 7 consecutive daily assessments of average pain on an 11 point (0-10) NRS with a recall period of 24 hours (item 4 of F GUPI-24h).
    8. Is confirmed to be willing to comply and has shown to be compliant with study requirements (such as completing questionnaires and diaries, compliance with study drug use and practicing a highly reliable method of birth control) and with attending all study visits.
    En la visita 1:
    1. Se ha obtenido el consentimiento informado por escrito. Se debe obtener del sujeto o de su representante legal autorizado el consentimiento informado por escrito y la autorización de uso de información personal aprobados por el Comité Ético de Investigación Clínica (CEIC) conforme a las normativas de cada país antes que poder realizar cualquier procedimiento vinculado al ensayo (incluida la retirada de medicamentos prohibidos, si procede).
    2. Se trata de una mujer de 18 años de edad o más y de procedencia étnica caucásica (blanca).
    3. Se le ha diagnosticado SDV/CI; es decir, dolor pélvico, presión o incomodidad percibida relacionada con la vejiga urinaria y que esté acompañada por al menos otro síntoma urinario como puede ser el constante deseo de miccionar o la frecuencia de micción, durante al menos 3 meses y con anterioridad a la fase de selección en ausencia de infección urinaria u otras patologías obvias o causas identificables.
    4. Tiene una puntuación de 4 o superior en la escala EVN de 11 puntos (de 0 a 10) en cuanto a dolor medio durante la semana previa, que es el ítem 4 del cuestionario F-GUPI.
    5. Debe utilizar un método anticonceptivo de alta fiabilidad. En caso de mujeres fértiles, los sujetos deben comprometerse a utilizar un método anticonceptivo de alta eficacia durante el ensayo. Como métodos anticonceptivos de alta eficacia se definen aquellos con una tasa de fallos baja (directriz CPMP/ICH/286/95 modificada) de menos del 1% al año cuando se utilicen de forma sistemática y correcta, tales como implantes, inyectables, anticonceptivos orales combinados, ciertos dispositivos intrauterinos (DIU), abstinencia sexual o pareja vasectomizada.
    6. Está preparada y dispuesta para cumplir con los requisitos del ensayo (p. ej., completar cuestionarios y diarios) y a asistir a todas las visitas del ensayo que sean necesarias.

    En la fase de aleatorización (visita 2/VI)
    7. Se confirma que tiene al menos dolor moderado según la PDMD con una puntuación mínima de 4,0. La PDMD es la media de las evaluaciones realizadas durante 7 días consecutivos del dolor medio según la escala EVN de 11 puntos (0-10) con un periodo de repetición en 24 horas (ítem 4 del F-GUPI-24h).
    8. Se confirma que está dispuesta a cumplir y se ha demostrado que cumple con los requisitos del ensayo (como la compleción de cuestionarios y diarios, el cumplimiento terapéutico con el fármaco de estudio, la utilización de un método anticonceptivo altamente eficaz) y la asistencia a todas las visitas del ensayo.
    E.4Principal exclusion criteria
    1. A positive pregnancy test (ß-HCG in serum) or be lactating.
    2. Undergone a CS with hydrodistension or undergone Botox injections in the bladder within 6 months prior to the screening visit.
    3. Been treated with pentosan polysulphate sodium within 4 weeks prior to the screening visit.
    4. Had any intravesicular pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide [DMSO]), or have had other interventions for BPS/IC (including electric stimulation therapy or acupuncture therapy) that may have affected disease symptoms within 3 months prior to the screening visit.
    5. Cystitis (radiation cystitis, Bacillus Calmette-Guérin (BCG)-induced cystitis, bacterial / tuberculous cystitis, cyclophosphamide cystitis) or had a documented symptomatic bacterial cystitis in the last 3 months prior to the screening visit.
    1. Se obtiene una prueba de embarazo positiva (hormona ß-GCH en suero) o está en fase de lactancia.
    2. Se ha sometido a una CS con hidrodistensión o se ha sometido a inyecciones de bótox en la vejiga en los 6 meses anteriores a la visita de selección.
    3. Se le ha tratado con pentosano polisulfato de sodio en las 4 semanas anteriores a la visita de selección.
    4. Ha recibido algún tratamiento farmacológico intravesicular relacionado con el SDV/CI (incluidos, entre otros, heparina o dimetil sulfóxido [DMSO]), o se ha sometido a otras intervenciones para tratar el SDV/CI (incluidos tratamientos de electroestimulación o de acupuntura) que hayan podido afectar a los síntomas de la enfermedad en los 3 meses anteriores a la visita de selección.
    5. Presenta cistitis (cistitis por radiación, cistitis inducida por el bacilo de Calmette-Guérin (BCG), cistitis bacteriana/tuberculosa, cistitis por ciclofosfamida) o ha padecido una cistitis bacteriana sintomática documentada en los 3 meses anteriores a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (last week of Run-in) in MDP at week 12 (the week prior to Visit 6/EoT). MDP is the mean of 7 consecutive daily assessments of pain. Pain is assessed on an 11 point (0-10) NRS with a recall period of 24 hours, which is item 4 of the F-GUPI-24h as recorded by the subject in the electronic diary.
    ? El cambio respecto al valor inicial (última semana de preinclusión) en la PDMD en la semana 12 (la semana previa a la visita 6/FdT). La PDMD es la media de la valoración del dolor durante 7 días consecutivos. El dolor se valora en una EVN de 11 puntos (0-10) con un periodo de repetición en 24 horas, que es el ítem 4 del F-GUPI-24h, registrado por el sujeto en el diario electrónico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 0, week 4, week 8, week 12, (week 14)
    semana 0, semana 4, semana 8, semana 12 ( semana 14)
    E.5.2Secondary end point(s)
    Change from baseline (Visit 2/BV) in F-GUPI Total score at week 12 (Visit 6/EoT).
    El cambio respecto al valor inicial (visita 2/VI) en la puntuación total del F-GUPI en la semana 12 (visita 6/FdT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0, week 4, week 8, week 12, (week 14)
    semana 0, semana 4, semana 8, semana 12 ( semana 14)
    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 No
    E.6.13Others No
    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 Yes
    E.8.1.7.1Other trial design description
    Diseño adaptativo
    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.8.2.4Number of treatment arms in the trial4
    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 EEA60
    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
    Denmark
    France
    Germany
    Latvia
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    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
    LVLS
    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 months10
    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 months10
    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 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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 300
    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)
    -
    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 Decision2012-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA