PRIMARY CHRONIC VENOUS DISEASE OF THE LOWER LIMBS
Conditions
Brief summary
Assessment of the change in Revised Venous Clinical Severity Score (rVCSS) score at V5 versus V1 in the two groups.
Detailed description
Efficacy: Assessment at V1 versus V2, V3 and V4 of rVCSS, Tolerability: Participants’ self-assessment of pain using a Visual Analog Scale (VAS), at V1 compared to V2, and V5, Tolerability: Participants’ self-assessment of quality of life in CVD using Chronic Venous Insufficiency Quality of Life (CIVIQ-20) Questionnaire, at V5 compared to V1, Safety: Quantitative and qualitative evaluation of safety in terms of Adverse Events (AEs) reported.
Interventions
DRUGHeparan Sulfate 120 MG Prolonged-release tablets
DRUGThe placebo is designed for oral administration and is formulated using the same excipients as the test product to ensure the same appearance
DRUGtablet shape
DRUGsize
DRUGand film coating.
Sponsors
Farmaceutici Damor S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the change in Revised Venous Clinical Severity Score (rVCSS) score at V5 versus V1 in the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Assessment at V1 versus V2, V3 and V4 of rVCSS, Tolerability: Participants’ self-assessment of pain using a Visual Analog Scale (VAS), at V1 compared to V2, and V5, Tolerability: Participants’ self-assessment of quality of life in CVD using Chronic Venous Insufficiency Quality of Life (CIVIQ-20) Questionnaire, at V5 compared to V1, Safety: Quantitative and qualitative evaluation of safety in terms of Adverse Events (AEs) reported. | — |
Outcome results
None listed