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).

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). International, multicenter, double-blind, randomized, parallel group study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003633-28-HU

Enrollment

570

Registered

2018-03-14

Start date

2018-05-02

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic Chronic Venous Disease (CVD). MedDRA version: 20.0 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866

Interventions

Product Name: Micronised purified flavonoid fraction Product Code: S05682 Pharmaceutical Form: Chewable tablet INN or Proposed INN: Micronized purified

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate the clinical non-inferiority of efficacy between micronised purified flavonoid fraction (MPFF) 1000 mg, 1 chewable tablet, and MPFF 500 mg, 2 tablets, in improving lower limb discomfort assessed by a 10 cm electronic visual analogue scale (eVAS) after 8 weeks of treatment in patients suffering from CVD. ;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	—

Measure

Time frame

Main Objective: to demonstrate the clinical non-inferiority of efficacy between micronised purified flavonoid fraction (MPFF) 1000 mg, 1 chewable tablet, and MPFF 500 mg, 2 tablets, in improving lower limb discomfort assessed by a 10 cm electronic visual analogue scale (eVAS) after 8 weeks of treatment in patients suffering from CVD. ;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

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Secondary

Measure	Time frame
Secondary end point(s): - Leg pain assessed by eVAS - Leg heaviness assessed by eVAS - Quality of life assessed by eCIVIQ - Adverse events, vital signs and overall acceptability ; Timepoint(s) of evaluation of this end point: - Leg pain assessed by eVAS: Selection visit, W000, W004, W008 - Leg heaviness assessed by eVAS: Selection visit, W000, W004, W008 - Quality of life assessed by eCIVIQ: Selection visit, W000, W004, W008 - Adverse events and vital signs: all over the study Overall acceptability: W008	—

Measure

Time frame

Secondary end point(s): - Leg pain assessed by eVAS - Leg heaviness assessed by eVAS - Quality of life assessed by eCIVIQ - Adverse events, vital signs and overall acceptability ; Timepoint(s) of evaluation of this end point: - Leg pain assessed by eVAS: Selection visit, W000, W004, W008 - Leg heaviness assessed by eVAS: Selection visit, W000, W004, W008 - Quality of life assessed by eCIVIQ: Selection visit, W000, W004, W008 - Adverse events and vital signs: all over the study Overall acceptability: W008

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Countries

Argentina, Austria, Brazil, Hungary, Romania, Russian Federation, Thailand, Turkey, Vietnam

Contacts

Public ContactContract Research Organization

INC Research, LLC

guillaume.leroux@syneoshealth.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026