E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign prostatic hyperplasia. |
Hiperplasia prostática benigna |
|
E.1.1.1 | Medical condition in easily understood language |
Benign enlargement of the prostate. |
Agrandamiento benigno de la próstata |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
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 | 10004446 |
E.1.2 | Term | Benign prostatic hyperplasia |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast 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 |
The objective of the study is to confirm in a larger and less selected population (?real life conditions?) the positive risk-benefit balance observed with silodosin 8 mg in double-blind, randomised clinical trials. |
El objetivo del estudio es confirmar en una población más grande y menos seleccionada ("condiciones de vida real") el balance riesgo-beneficio positivo observado con silodosina 8 mg en ensayos clínicos aleatorizados a doble ciego. |
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E.2.2 | Secondary objectives of the trial |
The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications. |
Se investigará también la efectividad y la seguridad del fármaco en diferentes subgrupos de pacientes de acuerdo con la edad, la intensidad de la enfermedad, las enfermedades y las medicaciones concomitantes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical diagnosis of BPH by the urologist; - Male subjects aged 60 years or older; - IPSS total score ?12 at Visit 1 (Screening) and 2 (Baseline); - Able to comply with protocol procedures; - Written informed consent obtained before beginning any investigational procedures. - Untreated patients or patients not adequately controlled or intolerant to current therapy for LUTS/BPH. Patients on current therapy with 5-alpha inhibitors (5-ARI) for whom, in the opinion of the investigator, a combined therapy is indicated, may be included. |
- Diagnóstico clínico de HPB realizado por el urólogo; - Sujetos varones de 60 años o más; - Puntuación total de la IPSS ? 12 en la visita 1 (Selección) y 2 (Momento basal); - Capaz de cumplir los procedimientos del protocolo; - Obtención del consentimiento informado por escrito antes de comenzar cualquier procedimiento de investigación. - Pacientes no tratados o pacientes no controlados adecuadamente o intolerantes a la terapia actual para SVUI/HPB. Pacientes tratados actualmente con inhibidores de la 5-alfa-reductasa (I5AR) para los cuales, en opinión del investigador, una terapia combinada es adecuada, podrían ser incluídos. |
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E.4 | Principal exclusion criteria |
- Hypersensitivity to the active substance or to any of the excipients; - Patients for whom cataract surgery is scheduled; - History of orthostatic hypotension or syncope; - Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula); - Severe hepatic impairment; - Concomitant use of other ?-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serulata/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline); - Concomitant use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible PK interaction); - Prostate cancer; - History of prostate or bladder neck surgery, including TURP, TUNA, laser or other minimally invasive therapy; - Active urinary tract infection; - Acute or recurrent prostatitis (more than 3 times in the last year); - History of neurological disease that may affect bladder function; - Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, PTCA, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months); - History or current evidence of drug or alcohol abuse within the last 12 months; - Participation in a study involving the administration of an investigational compound within the past 30 days; - Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study. |
- Hipersensibilidad al principio activo o a cualquiera de los excipientes; - Pacientes en los que esté programada cirugía de cataratas; - Antecedentes de hipotensión ortostática o síncope; - Insuficiencia renal moderada o intensa (AclCR <50 ml/min, estimado por la fórmula de Cockcroft Gault); - Insuficiencia hepática grave; - Uso simultáneo de otros antagonistas del receptor ?-adrenérgico o productos de herbolario/naturales con efecto conocido sobre los SVUI (p. ej., sabal - serenoa serulata/repens). Los pacientes que ya estén en tratamiento con esos fármacos pueden incluirse después de un período de lavado de 4 semanas antes de la visita 2 (momento basal); - Uso simultáneo de inhibidores potentes de CYP3A4, como ketoconazol, itraconazol o ritonavir (posible interacción FC); - Cáncer de próstata - Antecedentes de cirugía de próstata o del cuello vesical, incluidos RTUP, ablación transuretral con aguja de la próstata, láser u otro tratamiento mínimamente invasivo; - Infección activa de las vías urinarias; - Prostatitis activa o recurrente (más de 3 veces en el último año); - Antecedentes de enfermedad neurológica que pueda afectar a la función vesical; - Enfermedad cardiovascular o cerebrovascular inestable (como infarto agudo de miocardio, angina de pecho inestable, derivación coronaria, ACTP, insuficiencia cardíaca congestiva de clase III-IV, accidente cerebrovascular, accidente isquémico transitorio y episodios de arritmia cardíaca que precisen tratamiento en los últimos 6 meses); - Antecedentes o pruebas actuales de abuso de drogas o alcohol en los últimos 12 meses; - Participación en un estudio que conlleve la administración de un compuesto experimental en los últimos 30 días; - Cualquier otra enfermedad que, a criterio del investigador, haga que el sujeto sea incapaz de terminar el estudio o aumente el riesgo para el sujeto o que impida la participación óptima en la consecución de los objetivos del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to evaluate the effect of silodocin on LUTS in terms of IPSS response rate (decrease from baseline >=25% in the IPSS total score) |
El objetivo principal del estudio es evaluar los efectos de la silodosina sobre los SVUI en términos de tasa de respuesta en la IPSS (disminución ? 25% en la puntuación total IPSS respecto al valor basal). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Baseline to week +24. - Baseline to week +52 (only Spanish patients) |
- Desde visita basal hasta semana +24. - Desde visita basal hasta semana + 52 (sólo pacientes españoles) |
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E.5.2 | Secondary end point(s) |
The secondary objectives are: - effects on LUTS - effects on QoL due to urinary symptoms - safety profile - adherence to therapy - patient?s treatment satisfaction |
Los objetivos secundarios son: - efectos sobre los SVUI - efectos sobre la CdV debidos a los síntomas urinarios - perfil de seguridad - cumplimiento del tratamiento -satisfacción del paciente con el tratamiento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Baseline to week +24, follow-up information will be collected up to 4 - weeks by a phone contact. - Baseline to week +52, follow-up information will be collected up to 4 weeks by a phone contact (only Spanish patients). |
- Desde la visita basal a la semana +24, información de seguimiento hasta 4 semanas después vía telefónica. - Desde la visita basal a la semana +52, información de seguimiento hasta 4 semanas vía telefónica (sólo pacientes españoles) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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 (last visit last subject) |
Última visita del último sujeto |
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |