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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059617 |
E.1.2 | Term | Overactive bladder |
E.1.2 | System Organ Class | 100000004857 |
|
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 evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy |
Evaluar la eficacia de Solifenacina 5mg más Mirabegron 50mg vs Solifenacina 5mg Monoterapia. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the safety and tolerability of combination therapy versus solifenacin 5mg and solifenacin 10mg monotherapy - To evaluate the efficacy of combination therapy versus solifenacin 10mg monotherapy |
-Evaluar la seguridad y la tolerabilidad de el tratamiento combinado vs tratamiento monoterapia de Solifenacina 5mg y Solifenacina 10mg. -Evaluar la seguridad del tratamiento combinado vs tratamiento monoterapia 10mg. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject has symptoms of OAB (urinary frequency [an average of at least 8 episodes per day] and urgency with urgency incontinence) for > 3 months prior to the screening visit 2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit; 3. Subject has symptoms of ?wet? OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day. |
1. Pacientes con síntomas de VH (frecuencia urinaria y urgencia con incontinencia de urgencia) durante ?3 meses antes de la visita de selección.
2. Los pacientes deberán estar dispuestos y ser capaces de completar el diario miccional y los cuestionarios de forma correcta, incluyendo la recogida y medición del volumen de orina durante los 3 días previos a cada visita.
3.Pacientes con síntomas de VH «húmeda» (frecuencia urinaria y urgencia con incontinencia o incontinencia mixta con predominio de la incontinencia de urgencia) que presenten un promedio de al menos 2 episodios de incontinencia en 24 horas. |
|
E.4 | Principal exclusion criteria |
1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO). 2. Subject has significant PVR volume (PVR > 150 ml). 3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator 4. Subject has an indwelling catheter or practices intermittent self-catheterization. 5. Subject has evidence of a UTI. 6. Subject has 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 9. Subject has a clinically significant abnormal ECG 10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. 11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). 12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. 13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ? 180 mmHg and/or average diastolic blood pressure ? 110 mmHg. |
1.En opinión del investigador, el paciente presenta obstrucción vesical (BOO) clínicamente significativa. 2.Paciente con un volumen residual postmiccional significativo (RPM >150 mL). 3.Pacientes con un grado significativo de incontinencia de esfuerzo o incontinencia mixta de esfuerzo/urgencia en la que el esfuerzo sea el factor predominante, a juicio del investigador. 4.Pacientes con sondaje permanente o que realizan autosondajes intermitentes. 5.Pacientes con evidencia de infección del tracto urinario (ITU). 6.Pacientes con inflamación crónica, como cistitis intersticial, cálculos vesicales, radioterapia pélvica previa o tumor maligno previo o actual de los órganos pélvicos 7.Pacientes con alteración hepática moderada o grave 8. Pacientes con alteración renal grave 9. Pacientes con alteración del ECG clínicamente significativa 10. Pacientes con neoplasia maligna concomitante o con historial de cáncer (excepto en caso de cáncer de piel no invasivo) en los 5 últimos años previos a la selección. 11. Pacientes con un intervalo QTcF >450 mseg en el caso de los varones o >470 mseg en el caso de las mujeres, o que estén en riesgo de prolongación del intervalo QT (p. ej., historial familiar de síndrome QT largo o hipopotasemia). 12. Pacientes que han recibido tratamiento intravesical en los últimos 12 meses con, por ejemplo, toxina botulínica, resiniferatoxina o capsaicina. 13. Pacientes con hipertensión grave no controlada, que se define como una presión sistólica media en posición sentada ? 180 mm Hg y/o una presión diastólica media ? 110 mm Hg. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in mean number of incontinence episodes |
Cambio respecto a la visita basal en el número medio de episodios de incontinencia. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6). |
Visita Basal (Visita 3 /aleatorización) al fin de tratamiento (visit 6) |
|
E.5.2 | Secondary end point(s) |
Change from Baseline in mean number of micturitions per 24 hours |
Cambio respecto a la visita basal en el número medio de micciones en 24h. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline Visit (Visit 3/Randomization) to end of Treatment (Visit 6). |
Visita Basal (Visita 3 /aleatorización) al fin de tratamiento (visit 6) |
|
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.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 | No |
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 | 3 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 165 |
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 |
Algeria |
Armenia |
Australia |
Canada |
Egypt |
Georgia |
Israel |
Jordan |
Kazakhstan |
Korea, Republic of |
Lebanon |
New Zealand |
Russian Federation |
Taiwan |
Turkey |
Ukraine |
United States |
|
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
|
LSLV |
Última visita último paciente |
|
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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |