Clinical non-inferiority study between Daflon 1000 mg, one oral suspension in a sachet per day and Daflon 500 mg, 2 tablets daily after eight weeks of treatment in patients suffering from symptomatic Chronic Venous Disease (CVD).
- Conditions
- Patients suffering from symptomatic Chronic Venous Disease (CVD).MedDRA version: 14.1Level: LLTClassification code 10066682Term: Chronic venous insufficiencySystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-003559-13-ES
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 952
Inclusion Criteria
Patient 20 to 75 years old (inclusive),
Male or female,
Outpatients,
Patients suffering from primary chronic venous disease
Clinical class C0s to C4s on the most affected leg, according to the CEAP classification,
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 852
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
Pregnancy, breastfeeding or possibility of becoming pregnant during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the clinical non inferiority of efficacy between Daflon 1000 mg (1 sachet per day) and Daflon 500 mg (2 tablets per day), in improving lower limb discomfort assessed by a 10 cm visual analogue scale (VAS) after eight weeks of treatment in patients suffering from CVD;Secondary Objective: To determinate the evolution of efficacy during the study of each symptoms (leg pain, leg heaviness assessed by 10 cm Visual Analogue Scale), the quality of life evolution in both group (assessed by CIVIQ-20), and the safety profile and so, the acceptability of Daflon 1000 mg as compared to Daflon 500 mg.;Primary end point(s): To evaluate the efficacy of Daflon 1000 trough:<br> Lower limb discomfort related to CVD and assessed by a 10 cm visual analog scale;Timepoint(s) of evaluation of this end point: At selection (ASSE), W0, W2, W4 and W8.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1/ To evaluate the efficacy of Daflon 1000 trough:<br>Leg pain assessed by VAS <br>Leg heaviness assessed by VAS ,<br>Quality of life assessed by CIVIQ-20.<br><br>2/ To evaluate the safety of Daflon 1000 trough:<br>a/Adverse events, <br>b/vital signs and <br>c/overall acceptability.;Timepoint(s) of evaluation of this end point: 1/at selection (ASSE), W0, W2, W4 and W8,<br>2/ <br>a/b/ at each visit<br>c/ at W8