Contact information
Type
Scientific
Primary contact
Prof Alexander Kirienko
ORCID ID
Contact details
Russian State Medical University
1
Ostrovityanova Street
Moscow
117997
Russian Federation
-
clinicaltrials@servier.com
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
There are no secondary outcomes.
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
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
Current version as of 28/03/2018:
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Previous version as of 24/01/2018:
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-05682-107_synopsis_report.pdf
Publication summary