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    Summary
    EudraCT Number:2011-005307-33
    Sponsor's Protocol Code Number:P00048GP403
    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:2012-06-19
    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 number2011-005307-33
    A.3Full title of the trial
    Exploratory study of L.S.E.S.r. (PERMIXON 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH; a multinational, multicentric, randomised, double blind parallel-group prospective study.
    Studio esplorativo per valutare l'attivita' di L.S.E.S.r. (PERMIXON capsule rigide da 160 mg) versus Tamsulosina LP sui biomarcatori infiammatori nel trattamento dei sintomi urinari associati a IPB; studio prospettico internazionale, multicentrico, randomizzato, in doppio cieco e a gruppi paralleli.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory study of L.S.E.S.r. (PERMIXON 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH
    Studio esplorativo per valutare l’attivita' di L.S.E.S.r. (PERMIXON capsule rigide da 160 mg) versus Tamsulosina LP sui biomarcatori infiammatori nel trattamento dei sintomi urinari associati a IPB;
    A.4.1Sponsor's protocol code numberP00048GP403
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPierrre Fabre Medicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre de Recherche et De'veloppement Pierre Fabre
    B.5.2Functional name of contact pointPETILAIRE-BELLET Christine
    B.5.3 Address:
    B.5.3.1Street AddressCentre de Recherche et De'veloppement Pierre Fabre - BP 13562 - 3, avenue Hubert Curien
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post codeF- 31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 5 34 50 63 54
    B.5.5Fax number+33 5 34 50 65 92
    B.5.6E-mailchristine.petilaire.bellet@pierre-fabre.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 PERMIXON 160mg, capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Capsule, hard
    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 INNLIPIDOSTEROLIC EXTRACT OF SERENOA REPENS
    D.3.9.2Current sponsor codeP0048
    D.3.9.4EV Substance CodeSUB30163
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 Yes
    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 RoleComparator
    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 TAMSULOSINE ARROW LP 0,4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Prolonged-release capsule, hard
    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 INNTAMSULOSIN
    D.3.9.1CAS number 106133-20-4
    D.3.9.4EV Substance CodeSUB10827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.4
    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 placeboCapsule, hard
    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 placeboCapsule, hard
    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
    The aim of the proposed study is to assess the activity on inflammation biomarkers of L.S.E.S.r (PERMIXON 160mg hard capsule) and Tamsulosine LP in the treatment of BPH. The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.
    Lo scopo del presente studio è quello di vericare l'attività di L.S.E.S.r (PERMIXON 160mg capsule rigide) e Tamsulosin LP 0.4 mg sui biomarcatori infiammatori nel trattamento dell'IPB. Saranno valutati le potenziali correlazioni tra i biomarcatori infiammatori urinari e serici e la sintomatologia clinica dell'IPB al basale e nel corso del trattamento.
    E.1.1.1Medical condition in easily understood language
    Assessment of biomarkers of inflammation in BPH patients and their potential links with clinical symptoms.
    Valutazione dei biomarcatori infiammatori nell'IPB e loro potenziale correlazione con la sintomatologia clinica
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10004447
    E.1.2Term Benign prostatic hypertrophy
    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 evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. at D30 and D90 on biomarkers of inflammation in patients suffering from BPH : - Urine inflammation markers on the first urine flow : - Gene (mRNA) expression profile of inflammation in BPH - Protein expression profile of inflammation in BPH of the main expressed genes - Serum inflammation markers : - CRP and Sedimentation Rate
    Valutare l'effetto di L.S.E.S.r. 160 mg BID e Tamsulosina LP 0,4 mg OD dopo 30 e 90 giorni (D30 e D90) sui biomarcatori infiammatori nei pazienti affetti da IPB: - Marcatori infiammatori urinari sulle urine di prima emissione: - Profilo di espressione genica (mRNA) dell'infiammazione in presenza di IPB - Profilo di espressione proteica dell'infiammazione in presenza di IPB dei principali geni espressi -Marcatori infiammatori sierici: - PCR e VES
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of I-PSS. -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of QoL. - To assess the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on sexual function (MSF-4). -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of Qmax. -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of post-void residual urine volume. -To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on prostate volume. - To perform an exploratory analysis of the link between inflammation biomarkers and BPH clinical symptoms at baseline and on treatment.
    - Valutare efficacia di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD in base a punteggio I-PSS.- Valutare efficacia di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD in base a valutazione QoL.- Valutare effetto di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD sulla funzione sessuale (MSF-4).- Valutare efficacia di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD in base a valutazione Qmax.- Valutare efficacia di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD in base a valutazione di volume residuo post-minzionale.- Valutare effetto di L.S.E.S.r.160 mg BID e Tamsulosina LP 0,4 mg OD sul volume prostatico.- Eseguire una analisi esplorativa sulla correlazione fra marcatori infiammatori e sintomi clinici di IPB al baseline ed in corso di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male patient - Between 45 and 85 years old. - Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months - I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2) - Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2) - I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits, - 5 mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary) - Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2) - Serum total PSA at randomisation visit (visit 2) : a) ≤ 4 ng/mL b) ≤ 10 ng/mL and PSA (free) / PSA (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit. Ethical /legal considerations: - Patient able to understand and sign the informed consent and understand and fill in self-questionnaires - Having signed his written informed consent - Affiliated to a social security system, or is a beneficiary (if applicable in thenational regulation).
    - Paziente di sesso maschile - Età compresa fra 45 ad 85 anni - Paziente con sintomi fastidiosi a carico del basso tratto urinario ad esempio pollachiuria (diurna o notturna), urgenza, sensazione di svuotamento incompleto, minzione ritardata o flusso debole, protratti per un periodo superiore a 12 mesi - Punteggio I-PSS ≥ 10 alla visita di screening e ≥ 12 alla visita di randomizzazione (visita 2) - Malattia stabile alla randomizzazione, definita quale differenza assoluta pari o inferiore a 2 del punteggio I-PSS alla visita di randomizzazione (visita 2) rispetto alla visita di screening (visita 1) - Punteggio I-PSS QoL ≥ 3 registrato alle visite di screening e randomizzazione, - Velocità massima del flusso urinario ≥ 5 mL/s e &lt; 15 mL/s per un volume emesso ≥ 150 mL e ≤ 500 mL valutato in occasione della visita di randomizzazione (saranno eseguite 2 misurazioni, se necessario) - Volume prostatico ≥30 cm³ determinato mediante ecografia transrettale alla visita di randomizzazione (visita 2) - PSA totale sierico alla visita di randomizzazione (visita 2) : a) ≤ 4 ng/mL o b) ≤ 10 ng/mL e PSA (libero) / PSA (totale) ≥ 25% o biopsia prostatica negativa nei 6 mesi precedenti la visita di screening Considerazioni di natura etica/legale: - Paziente in grado di comprendere e firmare il consenso informato e di comprendere e compilare i questionari di autovalutazione - Paziente in grado di firmare il proprio consenso informato scritto - Paziente assistito dal sistema sanitario nazionale (se applicabile in base alla normativa nazionale).
    E.4Principal exclusion criteria
    - Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2). - Urological history : Urethral stricture disease and/or bladder neck disease Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection Urinary retention with indwelling catheter or intermittent catheterisation History of unprompted acute urinary retention in the past Indication of BPH surgery Stone in bladder or urethra Acute or chronic (documented) prostatitis Prostate cancer treated or untreated Bladder cancer Interstitial cystitis (documented by symptoms and/or biopsy) Active upper tract stone disease causing symptoms - Patient with history of surgery of the prostate, bladder neck or pelvic region - Any local and/or systemic inflammation disorders at selection and randomisation visit - Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle - Insulin-dependent diabetes mellitus and non-controlled non insulindependent diabetes mellitus - Chronic renal insufficiency, with serum creatinine ≥ 30 % above the upper normal range at randomisation visit (visit 2) - History of severe hepatic failure - Orthostatic hypotension defined as a decrease of at least 20 mmHg in SBP or 10 mmHg in DBP between supine and 2-minute standing positions at selection (visit 1) and randomisation visit (visit 2) - Patient with any severe underlying disease considered as life threatening in the short or medium term - Known hypersensitivity to one of the constituents of the study drugs - Concomitant medication with at selection visit (visit 1) and randomisation visit (visit 2) : Anti-androgens (must be discontinued at least 6 months prior to selection) LH-RH analogues (must be discontinued at least 6 months prior to selection) 5 alpha-reductase inhibitors (must be discontinued at least 3 months prior to selection) Plants extracts used for treatment of LUTS (must be discontinued at least 3 months prior to selection) Alpha blockers and alpha/beta blockers (must be discontinued at least 1 month prior to selection) ACE inhibitors, calcium antagonists, beta blockers or diuretics (except if stable dose and initiated more than 6 weeks prior to selection) NSAIDs by systemic route (except aspirin up to 325 mg/day for cardiovascular prophylaxis) Corticosteroids by systemic route. Antibiotics by systemic route Sympathomimetics, antihistamines, antidepressants (anticholinergic), atropine, antispasmodic drugs, antiparkinsonism drugs, pseudoephedrine, chlorpheniramine, spironolactone, mepartricine - Patient with a history of drug or alcohol abuse
    - Volume residuo post-minzionale &gt; 200 mL (mediante ecografia transrettale) alla visita di randomizzazione (visita 2). - Storia urologica: Stenosi uretrale e/o malattia del collo vescicale Infezione del tratto urinario in fase attiva (alle visite di screening e randomizzazione) o recente (&lt; 3 mesi) oppure ricorrente Ritenzione urinaria con catetere a dimora o cateterismo intermittente Storia di ritenzione urinaria acuta spontanea. Indicazione al trattamento chirurgico per IPB Litiasi vescicale o uretrale Prostatite acuta o cronica(documentata) Cancro prostatico, a prescindere dall’eventuale trattamento Carcinoma vescicale Cistite interstiziale (documentation da sintomi e/o biopsia) Calcolosi attiva e sintomatica delle alte vie urinarie - Paziente con storia di interventi chirurgici a prostata, collo vescicale o regione pelvica - Qualsiasi disturbo infiammatorio locale e/o sistemico rilevato alla visita di screening e randomizzazione - Qualsiasi patologia/disordine di natura neurologico psichiatrica che interferisce con la funzione del muscolo detrusore o sfintere - Diabete mellito insulino-dipendente e diabete mellito non insulino-dipendente non controllato - Insufficienza renale cronica, con valori sierici di creatinina ≥ 30 % oltre il limite superiore della normalità alla visita di randomizzazione (visita 2) - Storia di insufficienza epatica grave - Ipotensione ortostatica definita come una riduzione di almeno 20 mmHg nel valore PAS o di 10 mmHg nel valore PAD dalla misurazione in posizione supina alla misurazione rilevata dopo due minuti in posizione eretta, in occasione della visita di screening (visita 1) e di randomizzazione (visita 2) - Paziente con qualsiasi patologia sottostante grave considerata potenzialmente fatale nel breve o medio periodo - Nota ipersensibilità a uno dei componenti dei farmaci sperimentali - Terapia concomitante alla visita di screening (visita 1) e di randomizzazione (visita 2) con: Anti-androgeni (ammessi se interrotti almeno 6 mesi prima dello screening ) Analoghi LH-RH (ammessi se interrotti almeno 6 mesi prima dello screening ) Inibitori della 5-alfa reduttasi (ammessi se interrotti almeno 3 mesi prima dello screening) Prodotti erboristici utilizzati per il trattamento di sintomi a carico del basso tratto urinario (LUTS) (ammessi se almeno 3 mesi prima dello screening) Alfa bloccanti e alfa/betabloccanti (ammessi se interrotti almeno 1 mese prima dello screening) ACE inibitori, calcioantagonisti, betabloccanti o diuretici (eccetto se in trattamento stabile ed iniziati oltre 6 settimane prima dello screening) FANS sistemici (con l'eccezione dell'aspirina fino alla dose di 325 mg/die per profilassi cardiovascolare) Corticosteroidi sistemici Antibiotici sistemici Simpaticomimetici, antistaminici, antidepressivi (anticolinergici), atropina, antispasmodici, antiparkinsoniani, pseudoefedrina, clorfenamina, spironolattone, mepartricina - Paziente con storia di abuso di sostanze o alcolici
    E.5 End points
    E.5.1Primary end point(s)
    Inflammation biomarkers assay in patients suffering from BPH : - Urine inflammation markers (mRNA and proteins) on the first urine flow after digital rectal examination (DRE) at D1, D30 and D90 - Serum inflammation markers at D1, D30 and D90 : - CRP and Sedimentation Rate (at 1 hour & 2 hours)
    Dosaggio dei marcatori infiammatori urinari in pazienti affetti da IPB: - marcatori infiammatori urinari(mRNA e proteine) sulle urine di prima emissione dopo esame digitale rettale al giorno 1, 30 e 90. - Dosaggio dei marcatori serici dell'infiammazione al giorno 1, 30 e 90. - PCR e VES (a un'ora e due ore)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 01, Day 30, Day 90
    Giorno 01, Giorno 30, Giorno 90
    E.5.2Secondary end point(s)
    Secondary efficacy criteria : -Assessment of I-PSS at selection, D1, D30 and D90. -Assessment of QoL at selection, D1, D30 and D90. -Assessment of sexual function (MSF-4) at D1, D30 and D90. -Assessment of Qmax at D1, D30 and D90, by uroflowmetry - Assessment of post-void residual urine volume at D1, D30 and D90, by supra-pubic ultrasound - Assessment of prostate volume at D1, D30 and D90, by transrectalultrasound Safety criteria -Adverse events -Physical examination at selection visit and at each visit including body temperature and weight and height (at selection visit only) -Vital signs at selection visit and at each visit
    Efficacia : - Valutare il punteggio I-PSS alla selezione e ai giorni 1, 30, 90. - Valutazione QoL alla selezione e ai giorni 1, 30, 90. - Valutare la funzione sessuale (MSF-4)ai giorni 1, 30, 90. - Valutare il Qmax ai giorni 1, 30, 90. - Valutare il volume residuo post-minzionale ai giorni 1, 30, 90 con ecografia sovrapubica. - Valutare il volume prostatico ai giorni 1, 30, 90 con ecografia transrettale. Sicurezza: - Eventi Avversi - Esame obiettivo alla visita di selezione ed a ciascuna visita successiva compresa la misurazione della temperatura corporea, del peso e dell'altezza (solo alla visita di selezione). - Segni vitali alla visita di selezione ed a ciascuna visita successiva.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 01, Day 30, Day 90
    Giorno 01, Giorno 30, Giorno 90
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    studio esplorativo
    exploratory study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    No
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-08
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