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    Summary
    EudraCT Number:2015-004036-36
    Sponsor's Protocol Code Number:178-MA-1008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004036-36
    A.3Full title of the trial
    A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms
    While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
    Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato verso Placebo, di Fase 4 per Valutare l¿Efficacia, la Sicurezza e la Tollerabilit¿ di Mirabegron in Soggetti Maschi con Sintomi da Vescica Iperattiva (OAB) in Trattamento con l¿alfa bloccante Tamsulosina Cloridrato per i Sintomi delle Basse Vie Urinarie (LUTS) dovuti a Iperplasia Prostatica Benigna (IPB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of combined use of tamsulosin
    and mirabegron in men who have enlarged prostate and an overactive
    bladder
    Studio per valutare l'efficacia e la sicurezza dell'uso combinato di tamsulosina e mirabegron in soggetti maschi con ingrossamento della prostata e vescica iperattiva
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number178-MA-1008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstellas Pharma Global Development, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455878
    B.5.5Fax number0031715455224
    B.5.6E-mailraymond.vanaarle@astellas.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BETMIGA - 50 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - BLISTER (ALU/ALU) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBetmiga
    D.3.2Product code PRD746368
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BETMIGA - 25MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - BLISTER (ALU/ALU) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBetmiga
    D.3.2Product code PRD746368
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Over active bladder (OAB) in men with Lower Urinary Tract Symptoms
    (LUTS) due to Benign Prostatic Hyperplasia (BPH)
    Vescica Iperattiva (OAB) in soggetti maschi con sintomi delle basse vie urinarie dovuti a Iperplasia Porstatica Benigna (IPB)
    E.1.1.1Medical condition in easily understood language
    Over active bladder in men who also have an enlarged prostate with voiding problems
    Vescica iperattiva in soggetti maschi con ingrossamento della prostata con problemi di svuotamento della vescica
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10046543
    E.1.2Term Urinary incontinence
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking
    tamsulosin hydrochloride for LUTS due to BPH.
    Valutare l¿efficacia di mirabegron rispetto a placebo in uomini con sintomi da OAB in trattamento con tamsulosina cloridrato per LUTS dovuti a IPB.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of mirabegron versus placebo in men with OAB symptoms while
    taking tamsulosin hydrochloride for LUTS due to BPH.
    Valutare la sicurezza e la tollerabilit¿ di mirabegron rispetto a placebo in uomini con sintomi da OAB in trattamento con tamsulosina cloridrato per LUTS dovuti a IPB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited
    medication, if applicable).
    2. Men =40 years of age with history of OAB symptoms (urinary frequency and urgency with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to treat LUTS due to BPH.
    3. Subject has symptoms of OAB (frequency of =8 micturitions per day and urgency episodes of =2 per day) for =3 months prior to Screening.
    4. Subject has an IPSS score =8.
    5.Subject has Prostate-Specific Antigen (PSA) <4 ng/mL OR PSA =4 but <10 ng/mL with a prostate biopsy that is negative for cancer in the past year.
    6. Subject is willing and able to complete the 3-day diary (including urine volumes, vital sign measurements), and Quality of Life questionnaires.
    7. Subject and their spouses/partners who are of childbearing potential must be using a highly effective method of birth control, which includes
    established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from Screening and continue throughout the study and for 30 days after the final study drug administration. In addition, sperm donation will not be allowed throughout the study and for 30 days after the final study drug administration.
    8. Subject agrees not to participate in another interventional study while on treatment.
    Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
    9. Subject continues to meet all inclusion criteria of Visit 1 (Screening).
    10. Subject must experience an average of 8 or more micturitions per day over the 3-day diary period.
    11. Subject must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-day diary period.
    1.Consenso informato scritto e autorizzazione al trattamento dei dati ai sensi della normativa nazionale rilasciati dal soggetto o dal suo rappresentante legale su modulo approvato dal Comitato Etico, prima di poter eseguire qualsiasi procedura richiesta dallo studio (compresa l’interruzione di medicinali proibiti dal protocollo, se applicabile).
    2.Soggetto di sesso maschile di età =40 anni con storia di sintomi da OAB (frequenza urinaria e urgenza con o senza incontinenza) in trattamento con tamsulosina cloridrato 0.4mg QD da almeno 2 mesi per il trattamento di LUTS dovuti a IPB.
    3.Soggetto con sintomi da OAB (frequenza urinaria =8 minzioni al giorno e =2 episodi di urgenza al giorno) da = 3 mesi prima dello Screening.
    4.Soggetto con punteggio IPSS =8.
    5.Soggetto con livelli di PSA (Prostate-Specific Antigen) < 4 ng/mL o con livelli di PSA =4 ma <10 ng/mL per i quali è stata confermata assenza di neoplasia prostatica mediante biopsia effettuata nell’ultimo anno;
    6.Soggetto disposto ed in grado di compilare il diario elettronico (compresa la registrazione dei volumi di svuotamento, e la misurazione di segni vitali) e i questionari relativi alla qualità di vita.
    7.Il soggetto e la coniuge/partner in età fertile devono fare uso di contraccezione altamente efficace che comprenda l’uso, regolare da tempo, di metodi contraccettivi ormonali orali, iniettabili o impiantabili, dispositivo o sistema intrauterino (IUD o IUS). La contraccezione dovrà essere praticata a partire dallo Screening per l’intera durata dello studio, fino a 30 giorni dopo la somministrazione dell’ultima dose del medicinale sperimentale. Inoltre non sarà permessa la donazione di sperma per l’intera durata dello studio e per 30 giorni dopo la somministrazione dell’ultima dose del medicinale sperimentale.
    8.Soggetto che acconsente a non prendere parte ad altri studi interventistici durante il trattamento con il medicinale sperimentale.
    Criteri di Inclusione valutati alla Visita 2 (Baseline) in base ai dati registrati nel diario:
    9.Soggetto che continua a soddisfare tutti i criteri di inclusione previsti alla Visita 1 (Screening).
    10.Soggetto con una media di 8 o più minzioni al giorno durante i 3 giorni di compilazione del diario.
    11.Soggetto con una media di 2 episodi di urgenza (di grado 3 o 4) al giorno durante i 3 giorni di compilazione del diario.
    E.4Principal exclusion criteria
    1. Subject has PVR >200 mL.
    2. Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
    3. Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
    4. Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will
    be performed for positive leukocytes, nitrites, or turbidity, or at the Investigator’s discretion, and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject
    has a UTI, at Screening (Visit 1) the subject may be rescreened after successful treatment
    of the UTI (confirmed by a laboratory result of negative urine culture).
    5. Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
    6. Subject has diabetic neuropathy.
    7. Previous open, robotic or minimally invasive prostate surgery (including transurethral
    procedures). Planned (scheduled) pelvic or prostate surgery planned during the study
    period.
    8. Planned (scheduled) cataract surgery during the study period.
    9. Subject with significant stress incontinence as determined by the Investigator.
    10. Subject with clinically significant bladder outlet obstruction as determined by the
    Investigator.
    11. Subject has an indwelling catheter or practices intermittent self-catheterization.
    12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the
    last 12 months.
    13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such
    as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or
    current malignant disease of the pelvic organs (i.e., within the confines of the pelvis
    including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are
    not necessarily considered pelvic organs as the distal ascending colon, the full transverse
    colon and proximal portion of the descending colon are in the abdomen).
    14. Subject has received intravesical injection in the past 12 months with botulinum toxin,
    resiniferatoxin, or capsaicin.
    15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve
    stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
    16. Subject began or has changed a bladder training program or pelvic floor exercises less
    than 30 days prior to Screening.
    17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
    18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
    19. Subject has severe renal impairment defined as estimated creatinine clearance less than
    29 mL/min/1.73m2 as determined by central laboratory calculation of eGFR. A subject
    with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for
    the study.
    Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood
    pressure =180 mmHg and/or diastolic blood pressure =110 mmHg.
    21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
    22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2)
    electrocardiogram (ECG) defined as QTcF >450 msec.
    23. Subject has a clinically significant ECG abnormality, as determined by the Investigator.
    24. Subject has AST or ALT >2x upper limit of normal (ULN), or ¿-GT >3x ULN and
    considered clinically significant by the Investigator.
    25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin
    hydrochloride, or any of the inactive ingredients.
    26. Subject has a history of angioedema.
    27. Subject has any clinically significant condition, which in the opinion of the Investigator
    makes the subject unsuitable for study participation.
    28. Subject has been treated with an experimental device within 28 days or received an
    investigational agent within 28 days or 5 half-lives, whichever is longer, prior to
    Screening.
    29. Subject has a concurrent malignancy or history of any malignancy (within the past
    5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has
    been treated successfully.
    30. Subject has ongoing alcohol and/or drug abuse.
    31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days
    prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
    1.Soggetto con PVR >200 mL.
    2.Soggetto con Qmax <5,0 mL/secondo con volume minimo di svuotamento pari a 125 mL.
    3.Soggetto con ematuria >3 rbc/hpf che non sia ancora stata oggetto di indagini approfondite.
    4.Soggetto con evidenza di infezione delle vie urinarie (UTI). Saranno eseguiti urinocoltura e antibiogramma in caso di presenza nelle urine di leucociti o nitriti o di aspetto torbido delle urine, oppure a discrezione dello sperimentatore, e l’infezione urinaria sarà confermata in presenza di 100.000 UFC/ml all’urinocoltura). Se il soggetto presenta UTI allo Screening (Visita 1), potrà essere sottoposto a rescreening dopo trattamento e conferma di risoluzione dell’UTI (confermato da urinocoltura negativa).
    5.Soggetto con vescica neurologica (lesione midollare, sclerosi multipla, morbo di Parkinson, ecc.).
    6.Soggetto con neuropatia diabetica.
    7.Pregresso intervento chirurgico prostatico a cielo aperto, robotico o mini invasivo (comprese le procedure transuretrali). Pianificazione di intervento chirurgico pelvico o prostatico già programmato per il periodo dello studio.
    8.Intervento chirurgico per la cataratta pianificato (programmato) per la durata dello studio.
    9.Soggetto con significativa incontinenza da sforzo, a giudizio dello sperimentatore.
    10.Soggetto con ostruzione al collo vescicale clinicamente significativa, a giudizio dello sperimentatore.
    11.Soggetto con catetere a dimora o che fa ricorso autonomamente a cateterismo a intermittenza.
    12.Soggetto che ha avuto 3 o più episodi ricorrenti di infezione delle vie urinarie negli ultimi 12 mesi.
    13.Soggetto con infezione sintomatica delle vie urinarie, prostatite, infiammazione cronica (es. cistite interstiziale), calcolosi vescicale, pregressa radioterapia nella zona pelvica, neoplasia maligna pregressa o in atto a carico degli organi pelvici (organi all’interno della cavità pelvica, compresi vescica, prostata e retto; non tutti gli organi del tratto gastrointestinale inferiore sono necessariamente considerati organi pelvici, ad esempio il colon ascendente distale, l’intero colon trasverso e la porzione prossimale del colon discendente sono organi addominali).
    14.Soggetto che ha ricevuto iniezione intravescicale con tossina botulinica, resiniferatossina o capsaicina negli ultimi 12 mesi.
    15.Soggetto che in qualsiasi momento del passato è stato sottoposto a elettrostimolazione per OAB (ad esempio stimolazione elettrica del nervo sacrale oppure stimolazione percutanea del nervo tibiale [PTNS]).
    16.Il soggetto ha iniziato o modificato un programma di addestramento vescicale o esercizi del pavimento pelvico meno di 30 giorni prima dello Screening.
    17.Soggetto con ipotensione posturale oppure sincope o tachicardia posturale ortostatica.
    18.Soggetto con compromissione epatica moderata o grave, definita in base alla Classe B o C sec Child-Pugh.
    19.Soggetto con compromissione renale grave, determinata in base a valori di clearance della creatinina stimata inferiori a 29 mL/min/1,73m2 secondo calcolo dell’eGFR da parte del laboratorio centrale. Parimenti, i soggetti con malattia renale allo stadio terminale (ESRD) o dializzati non sono eleggibili per lo studio.
    20.Soggetto con ipertensione grave non controllata, definita in base a valori pressori sistolici =180 mmHg e/o diastolici =110 mmHg.
    21.Soggetto con valori baseline di frequenza cardiaca a riposo <60 b/min o >90 b/min.
    22.Soggetto con evidenza di prolungamento dell’intervallo QT (QTcF >450 msec) all’elettrocardiogramma eseguito allo Screening (Visita 1) o al Baseline (Visita 2).
    23.Soggetto con qualsiasi alterazione ECG considerata clinicamente significativa dallo sperimentatore.
    24.Soggetto con valori di AST o ALT >2 volte il limite superiore della norma (ULN), o valori di ¿-GT >3x ULN, considerati clinicamente significativi dallo sperimentatore.
    25.Soggetto con ipersensibilità a qualsiasi fra i componenti di mirabegron, tamsulosina cloridrato o a qualsiasi degli ingredienti inattivi.
    26.Soggetto con storia di angioedema.
    27.Soggetto con qualsiasi patologia clinicamente significativa e che a giudizio dello sperimentatore lo rende non adatto a partecipare allo studio.
    28.Soggetto che ha ricevuto trattamento con un dispositivo sperimentale nei 28 giorni precedenti lo Screening o che ha ricevuto un farmaco sperimentale nei 28 giorni o entro un periodo corrispondente a 5 emivite del farmaco sperimentale (quale dei due periodi sia più lungo) precedenti lo Screening.
    29.Soggetto con neoplasia maligna in atto o storia pregressa (negli ultimi 5 anni) di qualsiasi neoplasia maligna, ad eccezione del carcinoma cutaneo basocellulare o squamocellulare non metastatico che è stato trattato con successo.
    30.Soggetto con abuso attuale di alcolici/o stupefacenti.
    31.Soggetto che assume un medicinale proibito fra quelli elencati nell’Appendice 1, Parte A nei 30 giorni precedenti lo Screening (Visita 1) e fino al contatto telefonico di follow-up (Visita 6).
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline (Visit 2) to Week 12/ End of Treatment (Visit 5) in mean number of micturitions per day based on a 3-day diary
    • Variazione rispetto al Baseline (Visita 2) del numero medio di minzioni/24 ore secondo le informazioni registrate nel diario dei tre giorni, alla Settimana 12/Fine del Trattamento (Visita 5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    12 settimane
    E.5.2Secondary end point(s)
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean volume voided per micturition.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of incontinence episodes per day (FAS-I).
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of urgency episodes (grade 3 and 4) per day.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in IPSS total score and subscales (Voiding, Storage, and Quality of Life).
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of urgency incontinence episodes per day
    (FAS-I).
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in Symptom Bother Total Health Related Quality of Life and subscale (coping, concern, sleep, social interaction, and symptom bother) scores as assessed by OAB-q questionnaire.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) as assessed by EQ-5D-5L questionnaire.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in PPBC.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in Total Urgency and Frequency Score (TUFS) using PPIUS
    (Grade 3 or 4).
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of nocturia episodes per day.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in TS-VAS scores.
    ¿ Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in the number of protective garments (e.g. absorbent pads,
    incontinence briefs, disposable underwear).
    ¿Variazione rispetto al Baseline (Visita 2) del volume medio di urine emesso per minzione, alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del numero medio di episodi di incontinenza/24 ore (FAS-I), rilevato alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del numero medio di episodi di urgenza (di grado 3 e 4)/24 ore alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del punteggio IPSS, totale e sottocategorie (Svuotamento, Riempimento e Qualit¿ di Vita) alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del numero medio di episodi di incontinenza da urgenza/24 ore (FAS-I), alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del punteggio inerente l¿Impatto dei Sintomi e la Qualit¿ di Vita Correlata alla Salute e relative sottocategorie (capacit¿ di affrontare la situazione, preoccupazioni, sonno, interazione sociale, e il fastidio dovuto ai sintomi) mediante questionario OAB-q rilevati alla Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del punteggio EQ-5D-5L alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del punteggio PPBC alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del punteggio TUFS (Total Urgency and Frequency Score) mediante questionario PPIUS (Grado 3 o 4) alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del numero medio di episodi di nicturia/notte alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) dei punteggi TS-VAS alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    ¿Variazione rispetto al Baseline (Visita 2) del numero di indumenti protettivi usati (es, assorbenti, slip per incontinenza, biancheria usa e getta), alla Settimana 4, Settimana 8 e Settimana 12/Fine del Trattamento (Visita 5).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, 8 and 12
    4, 8 e 12 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czechia
    France
    Germany
    Italy
    Poland
    Slovakia
    Spain
    United Kingdom
    United States
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 439
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 878
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 659
    F.4.2.2In the whole clinical trial 1317
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After study is ended, standard clinical practises apply
    Al termine dello studio si applicher¿ la pratica clinica standard
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
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