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    Summary
    EudraCT Number:2014-004422-17
    Sponsor's Protocol Code Number:ANDRO-AOUC-2014-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-19
    Trial 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 number2014-004422-17
    A.3Full title of the trial
    Double-blinded placebo-controlled study on men with lower urinary tract symptoms secondary to prostatic hyperplasia (LUTS-BPH) to assess changes in pressure flow study (PFS) and in molecular profile of prostatic tissue and to correlate this parameters with modifications of symptoms scores (IPSS) after 12 weeks treatment with tadalafil
    Studio in doppio cieco, placebo-controllato su soggetti con sintomi delle basse vie urinarie (LUTS) secondari a iperplasia prostatica benigna (BPH) per valutare le variazioni nello studio pressione di flusso (PFS) e nel profilo molecolare del tessuto prostatico e correlare questi parametri con le variazioni nei punteggi dei sintomi (IPSS) dopo 12 settimane di trattamento con tadalafil.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the effect of 12 weeks of treatment with tadalafil in patients with symptoms of lower urinary tract secondary to hypertrophy of the prostate.
    Studio sull’effetto di 12 settimane di trattamento con tadalafil in pazienti con sintomi delle basse vie urinarie secondari a ipertrofia prostatica benigna.
    A.4.1Sponsor's protocol code numberANDRO-AOUC-2014-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02248467
    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 SponsorUNIVERSITY OF FLORENCE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly Italia SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOUC
    B.5.2Functional name of contact pointMedicina della Sessualità
    B.5.3 Address:
    B.5.3.1Street Addressviale Pieraccini 6
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50139
    B.5.3.4CountryItaly
    B.5.6E-mailm.maggi@dfc.unifi.it
    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 Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderELi Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.4EV Substance CodeSUB12602MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboFilm-coated 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
    lower urinary tract symptoms/benign prostatic hyperplasia
    sintomi delle basse vie urinarie in pazienti affetti da ipertrofia prostatica benigna
    E.1.1.1Medical condition in easily understood language
    lower urinary tract symptoms/benign prostatic hyperplasia
    sintomi delle basse vie urinarie in pazienti affetti da ipertrofia prostatica benigna
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10071289
    E.1.2Term Lower urinary tract symptoms
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast 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 assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.
    Valutazione in pazienti affetti da BPH in trattamento con alfa-bloccanti (Tamsulosina 0.4mg/die) e in attesa di intervento di TURP o prostatectomia semplice dell’efficacia di 12 settimane di trattamento con tadalafil rispetto a placebo nel migliorare la sintomatologia LUTS e quella infiammatoria ad essa associata, utilizzando dei questionari validati che esplorano non solo la sintomatologia LUTS (questionario IPSS) ma anche quella infiammatoria (NHI-CPSI).
    E.2.2Secondary objectives of the trial
    Improvement of pressure flow study (PFS) parameters
    Volumetric change of the prostate
    Change in prostate inhomogeneity and in the number of prostatic macrocalcifications
    BPH-associated prostate inhomogeneity and presence of micro-calcifications will be assessed by using male genital tract male genital tract colour-Doppler ultrasonography.
    Variation in genic expression of prostatic inflammation markers
    BPH-associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT-PCR analyses of inflammatory-, fibrosis- and hypoxia-related markers.
    Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate
    Improvement in metabolic profile
    Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index)
    Variation in seminal plasma IL-8 levels
    Improvement in erectile function
    Valutazione nei soggetti maschi adulti affetti da BPH in trattamento con alfa-bloccanti (Tamsulosina 0.4mg/die) e in attesa di trattamento chirurgico di TURP o prostatectomia semplice dell’efficacia del trattamento con tadalafil rispetto a placebo di:
    • variazioni del flusso urinario massimo (Qmax), flusso urinario medio (Qave), volume urinato (Vcomp (valori dello studio pressione/flusso (PFS)). Verrà eseguita un’ecografia addominale subito dopo l’uriflussimetria per determinare le variazioni del residuo post minzionale (PVR).
    • miglioramento dell’infiammazione prostatica BPH-associata valutata tramite le caratteristiche ultrasonografiche tipiche del processo prostatitico
    • miglioramento dell’infiammazione prostatica BPH-associata, la fibrosi e l’ipossia
    • miglioramento dei parametri metabolici
    • riduzione dei livelli di IL-8 nel liquido seminale.
    • miglioramento della funzionalità erettile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
    treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
    being capable of giving informed consent.
    18 Years and older
    1. Soggetti maschi adulti (>18 anni) in attesa di trattamento chirurgico (TURP o prostatectomia semplice)
    2. Soggetti in trattamento alfa-bloccanti (Tamsulosina 0.4mg/die)
    3. Soggetti in grado di comprendere, accettare e firmare il consenso informato allo studio
    E.4Principal exclusion criteria
    participation in another clinical study;
    known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value >10 ng/mL;
    suspected lack of the participant's compliance;
    known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
    nown neurogenic bladder (i.e. Parkinson's disease);
    suspected or proven urinary infections;
    presence of bladder stone.
    E.4 Criteri di esclusione principali:
    1. Arruolamento in altri protocolli
    2. Soggetti con malattia tumorale prostatica certa o sospetta o con PSA >10ng/mL
    3. Soggetti con patologie psichiatriche importanti ed accertate
    4. Soggetti non complianti
    5. Soggetti a conoscenza di gravi allergie al principio attivo o agli eccipienti del farmaco in questione
    6. Infezioni urinarie sospette o accertate
    7. Vescica neurologica o patologie neurologiche accertate
    8. Presenza di calcolosi vescicale
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of LUTS/BPH symptoms
    BPH-associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI). BPH-associated LUTS will be assessed by using International Prostate Symptom Score (IPSS).
    Miglioramento LUTS e sintomi IPB
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Improvement of pressure flow study (PFS) parameters
    Maximum flow rate (Qmax), average flow rate (Qave), voided volume (Vcomp), post void residual volume (PVR) will be evaluated. An abdominal ultrasound immediately after voiding for uroflowmetry will be performed in order to determine the PVR.
    Volumetric change of the prostate
    Change in prostate inhomogeneity and in the number of prostatic macrocalcifications
    BPH-associated prostate inhomogeneity
    • variazioni del flusso urinario massimo (Qmax), flusso urinario medio (Qave), volume urinato (Vcomp (valori dello studio pressione/flusso (PFS)).
    • l’infiammazione prostatica BPH-associata (inomogeneità, presenza di macro-calcificazioni, velocità di picco sistolico arterioso, aumento del volume della ghiandola prostatica).
    • l’infiammazione prostatica: parametri immunoistochimici e di espressione genica (qRT-PCR) dei marcatori infiammatori
    •parametri metabolici (glicemia, insulinemia, colesterolo totale, HDL, trigliceridi, HbA1c, pressione arteriosa, circonferenza vita, body mass index)
    • i livelli di IL-8 nel liquido seminale.
    • funzionalità erettile valutata con il questionario validato IIEF-5 (International Index of Erectile Dysfunction).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    ultima visita dell'ultimo soggetto
    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 months6
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state86
    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)
    None
    Nessuno
    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 Decision2015-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
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