E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overactive bladder |
Overactieve blaas |
|
E.1.1.1 | Medical condition in easily understood language |
Overactive bladder |
Overactieve blaas |
|
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. |
Het beoordelen van de werkzaamheid van mirabegron 50 mg versus solifenacine 5 mg bij de behandeling van proefpersonen met OAB die ontevreden waren over hun behandeling vanwege gebrek aan werkzaamheid. |
|
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. |
Het beoordelen van de veiligheid en verdraagbaarheid van mirabegron 50 mg versus solifenacine 5 mg bij de behandeling van proefpersonen met OAB die ontevreden waren over hun behandeling vanwege gebrek aan werkzaamheid. |
|
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. Patiënt heeft symptomen van OAB (frequent urineren en aandrang met of zonder aandrang-incontinentie) gedurende ≥ 3 maanden voorafgaand aan het screeningsbezoek.
2. Patiënt gebruikt op dit moment ten minste één antimuscarinicum bedoeld om de OAB te behandelen of heeft dit eerder gedaan.
3. De beoordeling van de tevredenheid over de laatste behandeling op de 7-punts Likert-schaal is uiterst, zeer of licht ontevreden, waarbij de belangrijkste oorzaak van de ontevredenheid ‘onvoldoende verlichting van symptomen van overactieve blaas’ is.
4. Patiënt is bereid en in staat om het mictiedagboek en de vragenlijsten correct in te vullen.
Zie protocol pagina 38-39 voor alle inclusie criteria. |
|
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. Patiënt heeft volgens de onderzoeker een klinisch significante blaasuitgangobstructie (BOO)
2. Patiënt heeft neurogene blaas.
3. Patiënt heeft significante stress-incontinentie of gemengde stress-/aandrang-incontinentie waarbij de onderzoeker heeft bepaald dat stress-incontinentie (druk) de dominante factor is (bij vrouwelijke patiënten bevestigd via een hoestprovocatietest).
4, Patiënt heeft een verblijfskatheter of past intermitterende zelfkatheterisatie toe.
5. Patiënt heeft diabetische neuropathie.
6. Patiënt heeft aanwijzingen voor een symptomatische urineweginfectie (urine dipstick wijst aanwezigheid van nitriet uit), chronische ontsteking zoals interstitiële cystitis, blaasstenen, eerdere bestralingstherapie van het bekken of eerdere of huidige kwaadaardige ziekte van de bekkenorganen.
7. Patiënt heeft matige tot ernstige leverinsufficiëntie gedefinieerd als Child-Pugh klasse B of C.
8. Patiënt heeft ernstige nierinsufficiëntie of terminale nierziekte gedefinieerd als eGFR < 29 ml/min/1,73 m2.
9. Patiënt heeft ernstige ongecontroleerde hypertensie, wat wordt gedefinieerd als een gemiddelde systolische bloeddruk ≥ 180 mm Hg en/of een gemiddelde diastolische bloeddruk ≥ 110 mm Hg in zittende houding.
10. Het laatste antimuscarinicum waarmee de patiënt is behandeld was solifenacine.
Zie protocol pagina 39-41 voor alle exclusie criteria. |
|
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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, Week 4, Week 8, Week 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 |
|
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 |
Enkel-blind gedurende de placebo run-in periode |
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 | 10 |
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
|
|
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 |