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    Summary
    EudraCT Number:2020-000110-15
    Sponsor's Protocol Code Number:SX-CVD3001/2020
    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:2021-05-20
    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 number2020-000110-15
    A.3Full title of the trial
    Multicentre, multinational, randomised, double blind, placebo-controlled study on Sulodexide for the management of leg symptoms in patients with chronic venous disease
    VEINS (VEnous INvestigation with Sulodexide)
    Studio multicentrico, internazionale, randomizzato, in doppio cieco, controllato verso placebo con Sulodexide per la gestione dei sintomi delle gambe in pazienti con malattia venosa cronica
    VEINS (VEnous INvestigation with Sulodexide)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on Sulodexide compared with placebo for the management of leg symptoms in patients with chronic venous disease
    Studio con Sulodexide verso placebo per la gestione dei sintomi delle gambe in pazienti con malattia venosa cronica
    A.3.2Name or abbreviated title of the trial where available
    VEINS (VEnous INvestigation with Sulodexide)
    VEINS (VEnous INvestigation with Sulodexide)
    A.4.1Sponsor's protocol code numberSX-CVD3001/2020
    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 SponsorALFASIGMA S.P.A.
    B.1.3.4CountryItaly
    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 supportALFASIGMA S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLB RESEARCH SRL
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia 81
    B.5.3.2Town/ cityCantù (CO)
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number0039031734908
    B.5.5Fax number00390317372218
    B.5.6E-mailinfo@lbresearch.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 VESSEL - 250 ULS CAPSULE MOLLI 50 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderALFASIGMA 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 nameSulodexide 250 LSU
    D.3.2Product code [Sulodexide]
    D.3.4Pharmaceutical form Capsule, soft
    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 INN00269900
    D.3.9.1CAS number 57821-29-1
    D.3.9.2Current sponsor codeSULODEXIDE
    D.3.9.4EV Substance CodeSUB04643MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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, soft
    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
    Chronic Venous Disease
    Malattia Venosa Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Venous Disease
    Malattia Venosa Cronica
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075049
    E.1.2Term Peripheral venous disease
    E.1.2System Organ Class 10047065 - Vascular 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 measure the extent of the effect of oral Sulodexide compared with placebo in reducing the intensity of leg symptoms associated with chronic venous disease.
    Misurare l'efficacia di Sulodexide orale rispetto al placebo nella riduzione dell'intensità dei sintomi delle gambe associati alla malattia venosa cronica.
    E.2.2Secondary objectives of the trial
    The secondary efficacy endpoints of the study will include:
    • A measure of patient-related outcome using the Visual Analogical Scale (VAS) for the overall health state, to be recorded at Baseline and at the Final Visit;
    • A measure of quality of life, using the questionnaire CIVIQ-14, to be recorded at Baseline and at the Final Visit.
    The Safety endpoints will include:
    • Recording of all adverse events according to the standard procedures;
    • Recording of vital signs (systolic and diastolic blood pressure and heart rate seated at rest) at Baseline, Intermediate Visit and Final Visit.
    Gli endpoint secondari di efficacia dello studio includeranno:
    • una valutazione dell'outcome correlato al paziente utilizzando la Scala Analogico Visiva (Visual Analogical Scale - VAS) per lo stato di salute generale, da registrare al Basale e alla Visita finale;
    • una valutazione della qualità della vita, utilizzando il questionario CIVIQ-14, da registrare al Basale e alla Visita finale.
    Gli endpoint di sicurezza includeranno:
    • registrazione di tutti gli eventi avversi in base alle procedure standard;
    • registrazione dei parametri vitali (pressione sanguigna sistolica e diastolica e frequenza cardiaca a riposo in posizione seduta) al Basale, alla Visita intermedia e alla Visita finale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients of age greater than or equal to 18 years;
    2. Able and willing to issue a signed informed consent after appropriate information and to provide a written authorization for disclosure of protected health information;
    3. With chronic venous disease;
    4. Classified by the attending physician in CEAP clinical classes 2 to 4;
    5. With symptomatic disease (where "symptomatic" disease in this study means: at least 2 symptoms among those composing the primary outcome measure and for a total of at least 6 score points);
    6. Female participants must be:
    - of non-childbearing potential, i.e.: post-menopausal (at least 2 years without spontaneous menses) or surgically sterile (bilateral tubal occlusion or hysterectomy) or ablation of both ovaries;
    or
    - of childbearing potential with a negative pregnancy test result at Visit 1 AND agreeing to use a highly effective method of contraception (i.e. with failure rate of less than 1% per year).
    1. Pazienti di sesso maschile e femminile di età maggiore o uguale a 18 anni;
    2. Capaci e disposti a rilasciare un consenso informato firmato dopo essere stati informati adeguatamente e a fornire un'autorizzazione scritta per il trattamento di informazioni sanitarie protette;
    3. Con malattia venosa cronica;
    4. Inseriti dal medico nelle classi da 2 a 4 della classificazione clinica CEAP.
    5. Con malattia sintomatica (in questo studio, l'espressione "malattia sintomatica" indica la presenza di almeno 2 dei sintomi considerati per la valutazione dell’outcome primario e per un totale di almeno 6 punti).
    6. Le partecipanti di sesso femminile devono essere:
    - non fertili, vale a dire in post-menopausa (almeno 2 anni senza mestruazioni spontanee) o sottoposte a sterilizzazione chirurgica (occlusione bilaterale delle tube o isterectomia) o ad ablazione di entrambe le ovaie;
    oppure
    - potenzialmente fertili con un test di gravidanza negativo alla Visita 1 E disposte a utilizzare un metodo contraccettivo ad alta efficacia (ossia con una percentuale di insuccesso inferiore all'1% annuo).
    E.4Principal exclusion criteria
    1. Patients considered, by the attending physician, unable to comply with the study procedures;
    2. Women who are pregnant or during puerperium (first 6 weeks after birth) or breastfeeding at the time of examination for inclusion in the study;
    3. Sexually active women, unless willing to apply an effective method of contraception during the study;
    4. Patients with a BMI greater than or equal to 35 at screening;
    5. Patients with active cancer or cancer in remission from less than 5 years;
    6. Patients with lymphoedema;
    7. Patients with chronic heart failure with swelling requiring diuretic treatment;
    8. Patients under any type of anticoagulant treatment;
    9. Patients receiving double anti-platelet therapy;
    10. Patients under treatment with drugs that may produce oedema (e.g., calcium antagonists);
    11. Patients under treatment with systemic and/or topical phlebotropic/vasotonic drugs or substances in the last 30 days prior to randomisation;
    12. Patients using compression stockings or bandages;
    13. Patients having had invasive treatment of the superficial or deep venous compartment of the lower legs (e.g., surgery, sclerotherapy, minimal invasive treatment for varicose veins);
    14. Patients participating in other clinical trials during the last 30 days prior to screening;
    15. Patients with known hypersensitivity or intolerance to study medications or their formulation excipients.
    1. Pazienti che il medico ritenga non in grado di attenersi alle procedure dello studio.
    2. Donne in gravidanza, in puerperio (prime 6 settimane dopo il parto) o in allattamento al momento dell'esame per l'inclusione nello studio.
    3. Donne sessualmente attive, a meno che non siano disposte ad adottare un metodo contraccettivo efficace nel corso dello studio.
    4. Pazienti con un indice di massa corporea maggiore o uguale a 35 allo screening.
    5. Pazienti con un cancro in fase attiva o un cancro in remissione da meno di 5 anni.
    6. Pazienti con linfedema.
    7. Pazienti con insufficienza cardiaca cronica accompagnata da gonfiore che necessita di un trattamento diuretico.
    8. Pazienti sottoposti a trattamenti anticoagulanti di qualsiasi tipo.
    9. Pazienti sottoposti a doppia terapia antiaggregante.
    10. Pazienti in trattamento con farmaci che potrebbero causare edema (ad esempio calcio-antagonisti).
    11. Pazienti in trattamento con sostanze o farmaci flebotropi/vasotonici per uso sistemico e/o topico nei 30 giorni antecedenti la randomizzazione.
    12. Pazienti che utilizzano calze o bendaggi compressivi.
    13. Pazienti sottoposti a trattamenti invasivi del compartimento venoso superficiale o profondo della parte inferiore delle gambe (ad esempio chirurgia, scleroterapia, trattamento mini-invasivo per le vene varicose).
    14. Pazienti che hanno partecipato ad altri studi clinici nei 30 giorni antecedenti lo screening.
    15. Pazienti con ipersensibilità o intolleranza nota ai medicinali in studio o agli eccipienti contenuti nella formulazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the change from baseline in leg symptoms intensity at the end of treatment.
    The primary measure is therefore the symptom intensity scoring, which will record – separately in the right and left leg - the intensity of the most common among the symptoms listed in the SYM Vein Consensus statement: pain/aching, heaviness, feeling of swelling, cramps, itching and fatigue.
    Each symptom in both legs will be scored with a 7-step scale: 0=absent; 1=barely perceptible, 2=mild, 3=moderate, 4=important, 5=severe, 6=unbearable. The total composite score, which may range 0 to 72, will be calculated and will represent the primary measure of the primary study endpoint.
    L'endpoint primario dello studio è la variazione rispetto al basale dell'intensità dei sintomi delle gambe al termine del trattamento.
    La variabile primaria è pertanto il punteggio relativo all'intensità dei sintomi, con il quale viene valutata, separatamente per la gamba destra e la gamba sinistra, l'intensità dei sintomi più comuni tra quelli riportati nel SYM Vein Consensus statement: dolore/indolenzimento, pesantezza, sensazione di gonfiore, crampi, prurito e affaticamento.
    A ciascun sintomo a carico delle due gambe sarà assegnato un punteggio su una scala a 7 livelli: 0 = assente; 1 = appena percettibile, 2 = lieve, 3 = moderato, 4 = importante, 5 = severo, 6 = insopportabile. Sarà calcolato il punteggio composito totale, compreso tra 0 e 72, che rappresenta la valutazione dell'endpoint primario dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days from baseline
    60 giorni dal basale
    E.5.2Secondary end point(s)
    Measure of patient-related outcome using the Visual Analogical Scale (VAS) for the overall health state, to be recorded at Baseline and at the Final Visit;; Measure of quality of life, using the questionnaire CIVIQ-14, to be recorded at Baseline and at the Final Visit.; Recording of all adverse events according to the standard procedures; Recording of vital signs (systolic and diastolic blood pressure and heart rate seated at rest) at Baseline, Intermediate Visit and Final Visit.
    Valutazione dell'outcome correlato al paziente utilizzando la Scala Analogico Visiva (Visual Analogical Scale - VAS) per lo stato di salute generale, da registrare al Basale e alla Visita finale; Valutazione della qualità della vita, utilizzando il questionario CIVIQ-14, da registrare al Basale e alla Visita finale.; Registrazione di tutti gli eventi avversi in base alle procedure standard; Registrazione dei parametri vitali (pressione sanguigna sistolica e diastolica e frequenza cardiaca a riposo in posizione seduta) al Basale, alla Visita intermedia e alla Visita finale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days from baseline; 60 days from baseline; Throughout the study; 30 and 60 days from baseline
    60 giorni dal basale; 60 giorni dal basale; Durante tutta la durata dello studio; 30 e 60 giorni dal basale
    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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Russian Federation
    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 months6
    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 months6
    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: 374
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 624
    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 Decision2021-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-28
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