Study on Sulodexide compared with placebo for the management of leg symptoms in patients with chronic venous disease

Phase 1

• Conditions: Chronic Venous Disease; MedDRA version: 20.0Level: PTClassification code 10075049Term: Peripheral venous diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000110-15-PL
• Lead Sponsor: Alfasigma S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 624

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified