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).

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003559-13-SI

Enrollment

952

Registered

2013-04-16

Start date

2013-05-20

Completion date

Unknown

Last updated

2015-11-16

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

Conditions

Patients suffering from symptomatic Chronic Venous Disease (CVD). MedDRA version: 14.1 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866

Interventions

Product Name: Micronized purified flavonoid fraction Product Code: S05682 Pharmaceutical Form: Oral suspension in sachet INN or Proposed INN: Micronized purified flavonoid fraction CAS Number: 111804-

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Pregnancy, breastfeeding or possibility of becoming pregnant during the study

Design outcomes

Primary

Measure	Time frame
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: 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.	—

Measure

Time frame

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: 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.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1/at selection (ASSE), W0, W2, W4 and W8, 2/ a/b/ at each visit c/ at W8;Secondary end point(s): 1/ To evaluate the efficacy of Daflon 1000 trough: Leg pain assessed by VAS Leg heaviness assessed by VAS , Quality of life assessed by CIVIQ-20. 2/ To evaluate the safety of Daflon 1000 trough: a/Adverse events, b/vital signs and c/overall acceptability.	—

Countries

Argentina, Brazil, Colombia, Czech Republic, Malaysia, Mexico, Romania, Russian Federation, Slovakia, Slovenia, Spain, Thailand, Turkey, Vietnam

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

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