E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10075049 |
E.1.2 | Term | Peripheral venous disease |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czechia |
Italy |
Poland |
Russian Federation |
Slovakia |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 20 |
E.8.9.2 | In all countries concerned by the trial days | 0 |