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    Summary
    EudraCT Number:2016-002984-32
    Sponsor's Protocol Code Number:FER-COM-16-004
    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:2018-02-05
    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 number2016-002984-32
    A.3Full title of the trial
    Treatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis
    Trattamento del Fenomeno di Raynaud a rischio di ulcere ischemiche in pazienti con sclerosi sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    ND
    A.3.2Name or abbreviated title of the trial where available
    ND
    ND
    A.4.1Sponsor's protocol code numberFER-COM-16-004
    A.5.4Other Identifiers
    Name:NDNumber:ND
    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 SponsorUNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
    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 supportAzienda Farmaceutica: ITALFARMACO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCLINICAL TRIAL CENTER
    B.5.2Functional name of contact pointCRO ACCADEMICA
    B.5.3 Address:
    B.5.3.1Street AddressL.GO A. GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0688805566
    B.5.5Fax number0688805567
    B.5.6E-mailbetty.polikar@policlinicogemelli.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 ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO S.P.A.
    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 nameENDOPROST
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNILOPROST TROMETAMOL
    D.3.9.1CAS number 73873-87-7
    D.3.9.2Current sponsor codeND
    D.3.9.3Other descriptive nameILOPROST SALE DI TROMETAMOLO
    D.3.9.4EV Substance CodeSUB14185MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 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 ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO S.P.A.
    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 nameENDOPROST
    D.3.2Product code ND
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNILOPROST TROMETAMOL
    D.3.9.1CAS number 73873-87-7
    D.3.9.2Current sponsor codeND
    D.3.9.3Other descriptive nameILOPROST SALE DI TROMETAMOLO
    D.3.9.4EV Substance CodeSUB14185MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SISTEMIC SCLEROSIS
    SCLEROSI SISTEMICA
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy, the safety and the feasibility of the slow infusion of Iloprost done at home, using the portable syringe pump INFONDE® in a group of patients affected by systemic sclerosis.
    Confermare l’efficacia, la sicurezza e la fattibilità dell’infusione lenta di Iloprost a domicilio mediante pompa siringa portatile INFONDE® in un gruppo di pazienti affetti da sclerosi sistemica
    E.2.2Secondary objectives of the trial
    • Patients’ Quality of Life, measured with the HAQ ( Health Assessment Questionnaire
    • Pharmacoeconomic assessments, related to the probable resources savings (direct and indirect costs), linked to the treatment made at home.
    Qualità della vita dei pazienti, misurata mediante il questionario HAQ (Health Assessment Questionnaire)
     Valutazioni di farmacoeconomia, relative al probabile risparmio di risorse (costi diretti ed indiretti) , ottenibile con il trattamento domiciliare
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent personally signed and dated by the patient, before any study procedure is implemented
    2. Diagnosis of Raynaud’ Disease, with or without presence of acral ulcers
    3. Age ≥ 18 and ≤ 80 years
    4. Check for proper venous assets (rated by experienced personnel) or central venous access
    5. Women of childbearing potential not willing to become pregnant during the course of the study and for 1 month following its completion
    6. Men having a relationship with women of childbearing age, who are willing not to get pregnant during the course of the study and for 1 month following its completion
    Consenso Informato firmato e datato dal paziente, prima di iniziare qualsiasi procedura prevista dallo studio
    2. Diagnosi di sclerodermia con Fenomeno di Raynaud, con presenza o meno di ulcere acrali
    3. Età ≥ 18 anni e ≤ 80 anni
    4. Verifica di patrimonio venoso adeguato (valutato da personale esperto) o dell’accesso venoso centrale
    5. Donne in età fertile disposte a non iniziare una gravidanza durante il corso dello studio e per 1 mese successivo al suo completamento
    6. Uomini che hanno una relazione con donne in età fertile che sono disposti a non procurare una gravidanza durante il corso dello studio e per 1 mese successivo al suo completamento
    E.4Principal exclusion criteria
    1. Patients with a disease characterized by advanced stages of deformation
    2. Contraindications to treatment with Iloprost and / or hypersensitivity to the active substance or to any of the excipients (trometamol, ethanol, 96% (v / v), sodium chloride, hydrochloric acid)
    3. Chronic renal failure (GFR <30 ml / min
    4. Liver Cirrhosis
    5. Surgery planned or executed by less than 3 months after initiation of treatment to the central nervous system and / or the eye; trauma surgery associated with large wounds exposed
    6. Severe Thrombocytopenia (PLT <20,000 / mmc) or severe anemia (Hb <8 g / dl)
    7. Severe and not controlled arterial hypertension
    8. Orthostatic hypotension
    9. Cephalalgia type of pathology and / or chronic vertigo evaluated by a reference specialist and / or for which the patient is undergoing a drug treatment
    10. Gastrointestinal pathology in acute phase
    11. Pregnancy and / or breast-feeding
    12. Severe coronary heart disease or unstable angina, myocardial infarction within six months preceding the start of treatment, acute or chronic congestive heart failure (NYHA II - IV), severe arrhythmias or relevant for prognosis
    13. Severe ischemic disorders of the lower limbs (grade III and IV)
    14. Smoking Patients with high levels of daily consumption and not willing to abstain during the treatment period
    15. Severe coagulation disorders, who need a stable regimen of treatment with anticoagulants or platelet aggregation inhibitors
    16. Patients with a neurological condition that makes them incapable of understanding the nature, purpose and possible consequences of the study
    17. Congestive heart failure
    Pazienti con malattia caratterizzata da stati di deformazione avanzati
    2. Controindicazioni al trattamento con Iloprost e/o ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti (trometamolo; etanolo, 96% (v/v); cloruro di sodio; acido cloridrico)
    3. Insufficienza renale cronica (VFG< 30 ml/min)
    4. Cirrosi epatica
    5. Intervento chirurgico previsto o eseguito da meno di 3 mesi dall’inizio del trattamento al sistema nervoso centrale e/o all’occhio; chirurgia traumatica associata a grandi ferite esposte
    6. Piastrinopenia severa (PLT <20000/mmc) o anemia severa (Hb <8 g/dl)
    7. Ipertensione arteriosa grave non controllata
    8. Ipotensione ortostatica
    9. Patologia di tipo cefalgico e/o vertigini croniche valutate da specialista di riferimento e/o per le quali il paziente risulta in trattamento farmacologico
    10. Patologia gastrointestinale in fase acuta
    11. Gravidanza e/o allattamento
    12. Coronaropatie gravi o angina instabile, infarto del miocardico nei sei mesi precedenti l’inizio del trattamento, insufficienza cardiaca congestizia acuta o cronica (NYHA II - IV), aritmie gravi o rilevanti per la prognosi
    13. Patologie ischemiche severe degli arti inferiori (grado III e IV)
    14. Pazienti fumatori, con elevati livelli di consumo quotidiano e non disposti all’astensione durante il periodo del trattamento
    15. Patologie coagulative severe, che necessitino un regime stabile di trattamento con anticoagulanti o inibitori dell’aggregazione piastrinica
    16. Pazienti affetti da una condizione neurologica che li renda incapaci di comprendere la natura, lo scopo e le possibili conseguenze dello studio
    17. Scompenso cardiaco congestizio
    E.5 End points
    E.5.1Primary end point(s)
    Raynaud’s Disease intensity, evaluated through the Raynaud’s Condition Score (RCS)
    Intensità del Fenomeno di Raynaud (FR) valutato mediante la Raynaud’s Condition Score (RCS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 MESI
    E.5.2Secondary end point(s)
     Ischemic ulcers incidence observed at 6 months of follow-up  Recovery time of the observed ischemic ulcers  Frequency and duration of the Raynaud’s Disease, evaluated through the Raynaud’s Condition Score (RCS)  Patients’ Quality of Life, measured with the HAQ ( Health Assessment Questionnaire  Completion rate of the entire home infusion cycle  Adverse Events incidence
    Incidenza di ulcere ischemiche a 6 mesi di follow-up  Tempo di guarigione delle ulcere ischemiche in studio  Frequenza e durata del Fenomeno di Raynaud (FR), valutato mediante la Raynaud’s Condition Score (RCS)  Qualità della vita misurata mediante il questionario HAQ (Health Assessment Questionnaire)  Tasso di completamento dell’intero ciclo di infusione a domicilio  Incidenza di eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 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 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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    STESSO FARMACO MA SOMMINISTRATO ATTRAVERSO POMPA DI INFUSIONE
    SAME DRUG ADMINISTRATED BY MEDICAL DEVICE
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned16
    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
    CLINICAL STUDY REPORT
    DISPONIBILITA' DEL CLINICAL STUDY REPORT
    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 months21
    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 months21
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-02-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state238
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 238
    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)
    NORMAL CLINICAL PRACTICE
    NORMALE PRATICA CLINICA
    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 Decision2016-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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