Condition category
Circulatory System
Date applied
05/05/2014
Date assigned
06/06/2014
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alexander Kirienko

ORCID ID

Contact details

Russian State Medical University
1
Ostrovityanova Street
Moscow
117997
Russian Federation

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-05682-107

Study information

Scientific title

Clinical acceptability study of micronized purified flavonoid fraction 1000 mg, one tablet per day compared to micronized purified flavonoid fraction 500 mg, two tablets daily after 8 weeks of treatment in patients suffering from symptomatic chronic venous disease (CVD): an international, multicenter, double-blind, randomized, parallel group study

Acronym

Study hypothesis

To demonstrate the clinical acceptability of Micronized Purified Flavonoid Fraction 1000 mg (one tablet per day) compared to Micronized Purified Flavonoid Fraction (Daflon®/Detralex®) 500 mg (two tablets per day) in patients suffering from CVD.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicenter double-blind randomized parallel-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic venous insufficiency

Intervention

Participants will be randomized to be treated with either one tablet taken daily of Micronized Purified Flavonoid Fraction 1000 mg or two 500 mg tablets taken daily for 8 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Daflon/Detralex

Primary outcome measures

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

N/A

Overall trial start date

19/12/2013

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

19/12/2013

Recruitment end date

01/07/2014

Locations

Countries of recruitment

Russian Federation, Serbia

Trial participating centre

Russian State Medical University
Moscow
117997
Russian Federation

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes