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    Summary
    EudraCT Number:2018-001418-14
    Sponsor's Protocol Code Number:VELOCE
    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:2021-05-20
    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 number2018-001418-14
    A.3Full title of the trial
    Assessment of clinical efficacy of Sildenafil 75 mg orodispersable film vs Sildenafil 100 mg tablet in patients with erectile dysfunction
    Valutazione dell’efficacia clinica del sildenafil 75mg film orodispersibile vs sildenafil 100 mg compresse nei pazienti con disfunzione erettile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the effects of two different formulations of the same drug on the ability to obtain and maintain an erection which is adequate for satisfying sexual activity
    Valutazione degli effetti di due diverse formulazioni dello stesso farmaco sulla capacità di ottenere e mantenere un’erezione adeguata al compimento di una soddisfacente attività sessuale
    A.3.2Name or abbreviated title of the trial where available
    FAST
    VELOCE
    A.4.1Sponsor's protocol code numberVELOCE
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    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 supportIBSA FARMACEUTICI SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSapienza Università di Roma
    B.5.2Functional name of contact pointDipartimento di Medicina Sperimenta
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number0649970540
    B.5.5Fax number06490530
    B.5.6E-mailandrea.isidori@uniroma1.it
    D. IMP Identification
    D.IMP: 1
    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 RABESTROM - " 75 MG FILM ORODISPERSIBILE " 8 FILM ORODISPERBILI IN BUSTINA AL/PET
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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.3.1Product nameRabestrom
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Sublingual film
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSILDENAFIL
    D.3.9.2Current sponsor codeN.A.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 SILDENAFIL PFIZER - 100 MG COMPRESSE RIVESTITE CON FILM 12 COMPRESSE IN BLISTER PVC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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.3.1Product nameSildenafil Pfizer
    D.3.2Product code [NA]
    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 INNSILDENAFIL
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameSildenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 RABESTROM - " 75 MG FILM ORODISPERSIBILE " 8 FILM ORODISPERBILI IN BUSTINA AL/PET
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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.3.1Product nameRabestrom
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Sublingual film
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSILDENAFIL
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameSildenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 4
    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 SILDENAFIL PFIZER - 100 MG COMPRESSE RIVESTITE CON FILM 12 COMPRESSE IN BLISTER PVC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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.3.1Product nameSildenafil Pfizer
    D.3.2Product code [NA]
    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 INNSILDENAFIL
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameSildenafil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erectile Dysfunction
    Disfunzione erettile
    E.1.1.1Medical condition in easily understood language
    Difficulty in achieving or maintaining an erection
    Difficoltà a ottenere e/o mantenere l’erezione
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    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
    Changes in the erectile function domain of questionnaires for assessment of erectile function
    Valutazione della variazione del dominio della funzione erettile nel contesto di questionari relativi allo studio della funzione sessuale maschile
    E.2.2Secondary objectives of the trial
    Changes in scores of questionnaires aimed to assess male sexual functioning, psychosexual features and sexual intimacy
    Valutazione della variazione del punteggio dei questionari relativi allo studio della funzione sessuale maschile, le caratteristiche psicosessuali e l’intimità sessuale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male patients aged 18-72, with a diagnosis of Erectile Dysfunction based on DSM-V criteria
    - Diagnosis of erectile dysfunction in the last 12 months
    - Previous use of PDE-5 inhibitors (discontinued for at least 2 weeks)
    - Written consent to participate to the study for its whole duration
    - Pazienti di sesso maschile, di età maggiore a 18 e inferiore a 72 anni, con diagnosi di Disfunzione Erettile sulla base dei criteri diagnostici del Manuale Diagnostico e Statistico dei Disturbi Mentali (DSM-V) ovvero: “costante impossibilità a raggiungere o a mantenere l’erezione adeguata fino al completamento dell’attività sessuale che causa un forte disagio o difficoltà interpersonali”
    - Recente diagnosi di Disfunzione Erettile (entro 12 mesi)
    - Pregresso uso di PDE5i (sospeso da almeno 2 settimane)
    - Adesione scritta al protocollo con disponibilità a partecipare allo studio per l’intera durata
    E.4Principal exclusion criteria
    - Psychiatric illnesses
    - Abuse of alcohol and/or psychoactive drugs
    - Neuropathies, including peripheral neuropathies
    - Chronic use of psychiatric drugs
    - Male hypogonadism with total testosterone <12 nmol/l.
    - Treatment with nitrates or androgens.
    - Anatomical penile abnormalities which might cause erectile dysfunction.
    - Severe or moderate kidney or liver disease, recent stroke or myocardial infarction, heart failure
    - Previous use of PDE-5 inhibitors or topically administered proerectile drugs in the last 2 weeks
    - Hypersensitivity to the active substance or any of the excipients
    - Diagnosis of hypotension (blood pressure <90/50 mmHg)
    - Participation to a different clinical trial in the previous 30 days or 5 times the active substance’s half-life
    - Any biochemical alteration which, following the Investigator’s clinical judgement, would make the patient unsuitable for the present study
    - Known hereditary retinal degenerative disorders, such as retinitis pigmentosa
    - Disturbi psichiatrici (schizofrenia, disturbi di personalità) con diagnosi specialistica.
    - Abuso di sostanze stupefacenti, alcol, farmaci psicotropi.
    - Patologie neurologiche incluse le neuropatie periferiche.
    - Uso cronico di farmaci psicotropi.
    - Ipogonadismo con testosterone totale <12 nmol/L.
    - Trattamento con nitroderivati e androgeni.
    - Alterazioni anatomiche peniene che possano favorire l’insorgenza di DE.
    - Severa e moderata insufficienza renale ed epatica, recente infarto del miocardio e stroke, diagnosi di insufficienza cardiaca
    - Uso di farmaci proerettili per os (PDE5 inibitori) o ad azione locale (PGE1) nelle ultime due settimane
    - Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti
    - Diagnosi di ipotensione (pressione arteriosa <90/50 mmHg)
    - Partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite del farmaco in studio.
    - Qualsiasi anomalia relativa ad esami di laboratorio che, a giudizio dello sperimentatore, renderebbe il paziente non idoneo per lo studio
    - Disturbi ereditari degenerativi accertati della retina, come retinite pigmentosa
    E.5 End points
    E.5.1Primary end point(s)
    Scores of the erectile function domain in the International Index of Erectile Dysfunction (IIEF-15)
    punteggi del dominio della funzione erettile dell’International Index of Erectile Dysfunction-(IIEF-15)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline, +3 months, + 6 months
    tempo 0, +3 mesi, +6 mesi
    E.5.2Secondary end point(s)
    Scores of the following questionnaires: Sexual Intimacy Rating Scale-SIRS, Orgasmometer, International Index of Erectile Dysfunction (IIEF-15), Premature Ejaculation Diagnostic Tool (PEDT), 90R-SCL90R; SIEDY; RQ e DAS.
    Punteggi dei questionari Sexual Intimacy Rating Scale-SIRS, Termometro dell’orgasmo-Orgasmometro, International Index of Erectile Dysfunction (IIEF-15), Premature Ejaculation Diagnostic Tool (PEDT), 90R-SCL90R; SIEDY; RQ e DAS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline, +3 months, + 6 months
    ai tempi 0, +3 mesi, +6 mesi
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 years1
    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 years1
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state118
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 118
    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)
    At the end of the Study, patients will be followed as by normal clinical practice.
    Al termine della sperimentazione i pazienti verranno indirizzati presso struttura ambulatoriale di riferimento per il proseguimento delle cure e per ulteriori valutazioni necessarie.
    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 Decision2019-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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