E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overactive Bladder |
Overactieve blaas |
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E.1.1.1 | Medical condition in easily understood language |
Overactive bladder |
Overactieve blaas |
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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 |
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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 evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy |
Het onderzoeken van de effectiviteit van solifenacine 5mg plus mirabegron 50 mg versus solifenacine 5mg monotherapie
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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 |
- Het onderzoeken van de veiligheid en verdraagzaamheid van de combinatietherapie versus solifenacine 5mg en solifenacine 10 mg monotherapie
- Het onderzoeken van de effectiviteit van de combinatietherapie ten opzichte van solifenacine 10mg monotherapie |
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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. De proefpersoon heeft symptomen van OAB (frequent urineren [een gemiddeld aantal van tenminste 8 episodes per dag] en aandrang met aandrang-incontinentie) gedurende ≥ 3 maanden voor het screeningsbezoek
2. Proefpersoon is bereid en in staat om het mictie dagboek en vragenlijsten correct in te vullen, waaronder het verzamelen en meten van de urineproductie gedurende 3 dagen voorafgaand aan elk bezoek;
3. Proefpersoon heeft symptomen van "natte" OAB (frequent urineren, aandrang met incontinentie of gemengde incontinentie met overheersend aandrang incontinentie), en rapporteert een gemiddelde van ten minste 2 incontinentie episodes per 24 uur.
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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. De proefpersoon heeft volgens de onderzoeker een klinisch significante blaasuitgang-obstructie (BOO).
2. De proefpersoon heeft een significant PVR volume (PVR> 150 ml).
3. De proefpersoon heeft aanzienlijke stress incontinentie of gemengde stress / urge-incontinentie waarbij de onderzoeker heeft bepaald dat 'stress' (drukverhogende momenten) de belangrijkste factor is.
4. De proefpersoon heeft een verblijfskatheter of past intermitterende zelf-katheterisatie toe.
5. De proefpersoon vertoont aanwijzingen voor een urineweginfectie (UWI).
6.De proefpersoon heeft een chronische ontsteking zoals interstitiële cystitis, blaasstenen, eerdere bestralingstherapie van het bekken, of eerdere of huidige kwaadaardige ziekte van de bekkenorganen
7. De proefpersoon heeft een matige tot ernstige leverfunctiestoornis.
8. De proefpersoon heeft een ernstige nierfunctiestoornis of nierziekte.
9. De proefpersoon heeft een klinisch significante abnormale ECG;
10. De proefpersoon heeft een maligniteit of een voorgeschiedenis van kanker (met uitzondering van niet-invasieve huidkanker) in de afgelopen 5 jaar voorafgaand aan screening.
11. De proefpersoon heeft een QTcF interval> 450 ms bij mannen of> 470 ms bij vrouwen of loopt het risico van QT-verlenging (bijvoorbeeld familiegeschiedenis van verlengd QT-syndroom, hypokaliëmie);
12. De proefpersoon heeft in de afgelopen 12 maanden intravesicale behandelingen gehad met bijvoorbeeld, botulinum toxine, resiniferatoxin, capsaïcine;
13. De proefpersoon heeft ernstige ongecontroleerde hypertensie, gedefinieerd als een zittende gemiddelde systolische bloeddruk ≥ 180 mmHg en / of gemiddelde diastolische bloeddruk ≥ 110 mmHg.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in mean number of incontinence episodes |
Verandering vanaf baseline van het gemiddelde aantal incontinentie episodes |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6). |
Baseline bezoek (visite 3/Randomizatie) tot aan Einde behandeling (visite 6) |
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E.5.2 | Secondary end point(s) |
Change from Baseline in mean number of micturitions per 24 hours |
Verandering vanaf baseline van het gemiddelde aantal micties per 24 uur |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline Visit (Visit 3/Randomization) to end of Treatment (Visit 6). |
Baseline bezoek (visite 3/Randomizatie) tot aan Einde behandeling (visite 6) |
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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 | 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 | 4 |
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 |
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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 | 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 |