E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vescica iperattiva |
Vescica iperattiva |
|
E.1.1.1 | Medical condition in easily understood language |
Overactive bladder |
Vescica iperattiva |
|
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. |
Valutare l’efficacia di Mirabegron 50 mg rispetto a Solifenacina 5 mg nel trattamento di soggetti affetti da vescica iperattiva (OAB) rimasti insoddisfatti dal trattamento ricevuto per mancanza di efficacia. |
|
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. |
Valutare la sicurezza e la tollerabilità di Mirabegron 50 mg rispetto a Solifenacina 5 mg nel trattamento di soggetti affetti da vescica iperattiva (OAB) rimasti insoddisfatti dal trattamento ricevuto per mancanza di efficacia. |
|
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.Il soggetto manifesta sintomi di vescica iperattiva (frequenza e urgenza urinaria con o senza incontinenza da urgenza) da ≥ 3 mesi prima della Visita di screening. 2.Il soggetto sta ricevendo o ha ricevuto in precedenza almeno un agente antimuscarinico per il trattamento della vescica iperattiva. L’ultimo antimuscarinico deve essere stato assunto per almeno 4 settimane e nei 6 mesi precedenti la Visita di screening. 3.La percezione della soddisfazione dell’ultimo trattamento valutato sulla scala Likert a 7 punti è estremamente, molto o leggermente insoddisfatto, avendo come causa principale dell’insoddisfazione “insufficiente sollievo dai sintomi della vescica iperattiva”. 4.Il soggetto è disposto e in grado di compilare correttamente il diario minzionale e i questionari. |
|
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 selfcatheterization. 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.Il soggetto, presenta un’ostruzione cervico-uretrale (Bladder Outlet Obstruction, BOO) clinicamente significativa. 2.Il soggetto è affetto da vescica neurogena 3.Il soggetto presenta una significativa incontinenza da stress oppure una combinazione di incontinenza da stress e da urgenza, dove lo stress è il fattore predominante. 4.Il soggetto ha un catetere a permanenza o pratica l’autocateterizzazione intermittente. 5.Il soggetto presenta neuropatia diabetica. 6.Il soggetto presenta segni di infezione sintomatica del tratto urinario (stick urinario con presenza di nitriti), infiammazione cronica come cistite interstiziale, calcoli vescicali, precedente radioterapia pelvica o patologia maligna precedente o attuale agli organi pelvici. 7.Il soggetto presenta un’insufficienza epatica da moderata a grave. 8.Il soggetto presenta una grave insufficienza renale o malattia renale allo stadio terminale. 9.Il soggetto manifesta ipertensione grave non controllata 10.L’ultimo trattamento antimuscarinico del soggetto era a base di 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. |
Variazione dal basale del numero medio di minzioni ogni 24 ore, sulla base di un diario minzionale di 3 giorni. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, Week 4, Week 8, Week 12 |
Giorno 1, Settimana 4, Settimana 8, Settimana 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. |
Porzione di soggetti che riportano almeno un evento avverso emergente dal trattamento, quale secchezza delle fauci, stipsi o offuscamento della vista durante il periodo di trattamento in doppio cieco |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 - week 12 |
Giorno 1-Settimana 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tollerabilità |
|
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 |
Cieco durante la fase preliminarecon 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 | 11 |
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 |
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
|
LVLS |
Ultima Visita Ultimo Paziente |
|
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 |