Clinical non-inferiority study between Micronized purified flavonoid fraction 1000 mg, one chewable tablet per day and Micronized Purified Flavonoid Fraction 500 mg, 2 tablets daily after eight weeks of treatment in patients suffering from symptomatic Chronic Venous Disease (CVD).
- Conditions
- symptomatic Chronic Venous Disease (CVD).MedDRA version: 20.0 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-003633-28-AT
- Lead Sponsor
- Institut de Recherches Internationales SERVIER (I.R.I.S.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 570
- patient 20 to 75 years old inclusive,
- male or female,
- 18 kg/m² = BMI = 35 kg/m²,
- suffering from primary chronic venous disease, with lower limb discomfort superior or equal to
4 cm on eVAS,
- clinical class C0s to C4s on the most affected leg, according to the Clinical Etiological Anatomic
Pathophysiologic (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 524
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
- unlikely to co-operate in the study,
- unable to fill in a questionnaire or a ePRO by himself,
- severe locomotor disability,
- patient who had a total or partial leg/foot amputation,
- pregnancy, breastfeeding, or woman of child bearing potential without an effective contraceptive
method.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: to demonstrate the clinical non-inferiority of efficacy between micronised purified<br> flavonoid fraction (MPFF) 1000 mg, 1 chewable tablet, and MPFF 500 mg, 2 tablets, in<br> improving lower limb discomfort assessed by a 10 cm electronic visual analogue scale (eVAS) after 8 weeks<br> of treatment in patients suffering from CVD.<br> ;Secondary Objective: to determine the evolution of efficacy during the study according to each symptom (leg pain and leg heaviness assessed by 10 cm eVAS), the quality of life evolution in both groups (assessed by electronic Chronic Venous Insufficiency quality of life Questionnaire), the safety profile, and the acceptability of MPFF 1000 mg chewable tablet as compared to MPFF 500 mg;Primary end point(s): Lower limb discomfort assessed by eVAS;Timepoint(s) of evaluation of this end point: Selection visit, W000, W004, W008
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - Leg pain assessed by eVAS<br> - Leg heaviness assessed by eVAS<br> - Quality of life assessed by eCIVIQ<br> - Adverse events, vital signs and overall acceptability<br> ;<br> Timepoint(s) of evaluation of this end point: - Leg pain assessed by eVAS: Selection visit, W000, W004, W008<br> - Leg heaviness assessed by eVAS: Selection visit, W000, W004, W008<br> - Quality of life assessed by eCIVIQ: Selection visit, W000, W004, W008<br> - Adverse events and vital signs: all over the study<br> Overall acceptability: W008<br>