Chronic Venous Disease MedDRA version: 20.0 Level: PT Classification code 10075049 Term: Peripheral venous disease System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Vessel
Product Name: Sulodexide 250 LSU
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: SULODEXIDE
CAS Number: 57821-29-1
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Alfasigma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients of age = 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 374 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
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 = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;Primary 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. ;Timepoint(s) of evaluation of this end point: 60 days from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be evaluated 60 days from baseline Secondary efficacy endpoints will be evaluated throughout the study | — |
Countries
Czechia, Czech Republic, Italy, Poland, Portugal, Russian Federation, Slovakia
Contacts
Public ContactClinical Operations
LB Research s.r.l
Outcome results
None listed