This multicenter, randomized, double-blind study is a phase III evaluates the safety and effectiveness of CLR prolonged-release tablets in patients with chronic venous insufficiency, has been shown to be effective in reducing the symptoms of itching, edema, spontaneous pain, and night cramps chronic venous disease.
Participants with an age ≥ 18 and ≤ 80 years
Diagnosed primary venous disease of the lower limbs in stage C2 - C5 according to the CEAP classification, involvement of the venous system of the lower limbs is verified by duplex ultrasonography
Presence of objective signs and subjective symptoms of the disease (classified according to rVCSS score ≥ 4)
Participants not using or planning to use compression therapy by their own decision
Use of a venoactive drug in the last month
Regular use of compression therapy or use of mechanical devices for reduction of edema in the last month
Heart Failure (NYHA class III and IV), congestive heart failure with peripheral edema
eGFR < 30 mL/min/1.73 m² at screening or chronic kidney disease documented in the medical history
Parallel
CLR Tablets - Heparan Sulphate
DrugOral heparan sulphate tablets, one tablet administered once daily for one year.
CLR Placebo
Other interventionOral placebo tablets administered once daily for one year.
Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5
Revised Venous Clinical Severity Score (rVCSS) at Visit 5 (V5) compared to Visit 1 (V1) in the two groups. The rVCSS is a clinical scale used to assess the severity of chronic venous disease. The total score ranges from a minimum of 0 (indicating no venous disease) to a maximum of 30 (indicating severe venous disease). Higher scores mean a worse clinical outcome.
Participant Self-Assessment of Pain Severity via Visual Analog Scale (VAS) at Visit 2 and Visit 5 Compared to Visit 1
Pain severity assessed by the participant using the Visual Analog Scale (VAS). The unabbreviated scale title is the Visual Analog Scale. The score ranges from a minimum value of 0 (representing "no pain") to a maximum value of 100 (representing "the worst possible pain"). Higher scores mean a worse outcome (greater pain severity). Unit of measure: score
Quality of Life Assessment via Chronic Venous Insufficiency Quality of Life (CIVIQ-20) Questionnaire at Visit 5 Compared to Visit 1
Quality of life specific to chronic venous disease assessed via the Chronic Venous Insufficiency Quality of Life (CIVIQ-20) Questionnaire. The total score ranges from a minimum of 20 (excellent quality of life/no symptoms) to a maximum of 100 (worst quality of life/severe symptoms). Higher scores mean a worse outcome. Unit of measure: score
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability evaluated through the quantitative and qualitative assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs) reported throughout the study period. Unit of measure: Percentage of Participants
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Barbara Maglione
Lead sponsor
Farmaceutici Damor Spa
Sponsor institution
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