E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overactive bladder |
Vejiga Hiperactiva |
|
E.1.1.1 | Medical condition in easily understood language |
Overactive bladder |
Vejiga Hiperactiva |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
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 | 10059617 |
E.1.2 | Term | Overactive bladder |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
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 assess the efficacy of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy. |
Para valorar la eficacia de mirabegron 50mg frente Solifenacina 5mg en el tratamiento de sujetos con vejiga hiperactiva que están insatisfechos con su último tratamiento debido a la falta de eficacia. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy. |
Para valorar la seguridad y tolerabilidad de mirabegron 50mg frente Solifenacina 5mg en el tratamiento de sujetos con vejiga hiperactiva que están insatisfechos con su último tratamiento debido a la falta de eficacia. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for ? 3 months prior to the Screening Visit.
2.Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB.
3.The perception of the last treatment satisfaction on a 7 item Likert scale is extremely, very, or slightly dissatisfied.
4.Subject is willing and able to complete a micturition diary and questionnaires. |
1. Paciente con síntomas de VH (frecuencia urinaria y urgencia, con o sin incontinencia de urgencia) durante ≥3 meses antes de la visita de selección.
2.El paciente está recibiendo o ha recibido previamente al menos un antimuscarínico para el tratamiento de su VH.
3.La percepción de satisfacción con el último tratamiento, evaluada sobre una escala Likert de 7 ítems, es extremadamente insatisfactoria, muy insatisfactoria o ligeramente insatisfactoria, y la principal causa de la
insatisfacción es «un alivio insuficiente de los síntomas de vejiga hiperactiva». 4. El paciente es capaz y está dispuesto a completar correctamente el diario miccional y los cuestionarios. |
|
E.4 | Principal exclusion criteria |
1.Subject has clinically significant Bladder Outlet Obstruction (BOO).
2.Subject has neurogenic bladder.
3.Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
4.Subject has an indwelling catheter or practices intermittent self-catheterization.
5.Subject has diabetic neuropathy.
6.Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
7.Subject has moderate to severe hepatic impairment.
8.Subject has severe renal impairment or End Stage Renal disease.
9.Subject has severe uncontrolled hypertension.
10.Subject?s last anti-muscarinic treatment was solifenacin. |
1. el paciente presenta obstrucción urinaria (BOO) clínicamente significativa.
2.El paciente presenta vejiga neurógena.
3.El paciente tiene incontinencia de esfuerzo significativa o incontinencia mixta (esfuerzo/urgencia) en la que el esfuerzo es el factor predominante.
4. El Paciente requiere sondaje permanente o intermitente.
5. El paciente tiene neuropatía diabética.
6. El pacientes presenta, en la visita basal, evidencia de infección sintomática del tracto urinario (presencia de nitritos
en la prueba de tira reactiva), inflamación crónica como la cistitis intersticial, cálculos vesicales, radioterapia pélvica previa o patología maligna previa o actual de los órganos
pélvicos.
7.El pacientes tiene alteración hepática moderada o severa.
8. alteración renal severa o enfermedad renal terminal
9. hipertensión severa no controlada.
10. El último tratamiento antimuscarínico que ha recibido el paciente ha sido solifenacina. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary. |
Cambio respecto a la visita basal en el número medio de micciones en 24 horas, basado en un diario miccional de 3 días. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, Week 4, Week 8, Week 12 |
Día 1, Semana 4, Semana 8, Semana 12. |
|
E.5.2 | Secondary end point(s) |
Proportion of subjects reporting at least one treatment-emergent adverse event of dry mouth, constipation or blurred vision during double-blind treatment period. |
Proporción de pacientes que presentan al menos un acontecimiento adverso aparecido durante el tratamiento en el periodo doble ciego, de sequedad de boca, estreñimiento o visión borrosa. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 - week 12 |
Día 1- Semana 12 |
|
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 | 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.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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) | Yes |
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 |
simple ciego durante el periodo run-in placebo |
Single-blind during the placebo run-in period |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 160 |
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 |
Armenia |
Australia |
Belarus |
Canada |
Croatia |
Egypt |
Georgia |
Jordan |
Kazakhstan |
Lebanon |
Russian Federation |
Switzerland |
Turkey |
Ukraine |
|
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
|
LSLV |
Útima visita del último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 | 0 |
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 |