Clinical acceptability study in patients suffering from chronic venous disease (CVD) comparing micronized purified flavonoid fraction (MPFF) 1000 mg, one tablet daily, to MPFF 500 mg tablet twice a day

Not Applicable

Completed

• Conditions: Chronic venous insufficiency; Circulatory System; Venous insufficiency (chronic)(peripheral)

• Registration Number: ISRCTN53430167
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Study Completion: 2014-07-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or female patient aged 20 to 70 years old (inclusive)
2. Out-patient
3. Suffering from primary chronic venous disease (leg pain greater or equal to 4 cm on Visual Analog Scale)
4. Clinical class C0s to C4s on the most affected leg (CEAP classification)

Exclusion Criteria

1. Pregnancy, breastfeeding or possibility of becoming pregnant
2. Recent non-authorized nonpharmacological treatments (sclerotherapy; surgical treatment of varicose veins, angioplasty; endovascular devices)
3. Recent compression therapy and/or physical therapy of legs
4. Active venous thrombosis, significant chronic deep venous obstruction leading to venous claudication and significant compression therapy
5. All causes of leg pain in lower limbs others than CVD symptoms

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (clinical acceptability) assessed at each visit (week 0, week 2, week 4 and week 8). Safety assessment takes into account adverse events, weight, sitting blood pressure and heart rate, laboratory examination and leg pain by Visual Analog Scale.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcomes.