E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bladder Pain Syndrome / Interstitial Cystitis |
Síndrome de Dolor Vesical/Cistitis Intersticial |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain in bladder and pelvic area |
Dolor crónico en la vejiga y área pélvica |
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E.1.1.2 | Therapeutic 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.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011796 |
E.1.2 | Term | Cystitis interstitial |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008927 |
E.1.2 | Term | Chronic interstitial cystitis |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008928 |
E.1.2 | Term | Chronic interstitial cystitis NOS |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071166 |
E.1.2 | Term | Bladder pain syndrome |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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 |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Diseño adaptativo |
adaptive design |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If 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 |
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E.8.7 | Trial 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
|
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |