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

ISRCTN	ISRCTN53430167
DOI	https://doi.org/10.1186/ISRCTN53430167
Secondary identifying numbers	CL3-05682-107

Submission date: 05/05/2014
Registration date: 06/06/2014
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Alexander Kirienko
Scientific

Russian State Medical University
1, Ostrovityanova Street
Moscow
117997
Russian Federation

Email	clinicaltrials@servier.com

Study information

Study design	International multicenter double-blind randomized parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Daflon/Detralex
Primary outcome measure	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 study start date	19/12/2013
Completion date	01/07/2014

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	150
Key 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)
Key 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
Date of first enrolment	19/12/2013
Date of final enrolment	01/07/2014

Locations

Countries of recruitment

Russian Federation
Serbia

Study participating centre

Russian State Medical University

Moscow
117997
Russian Federation

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 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 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No

Editorial Notes

18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
04/12/2017: results summary added.
09/05/2017: contact email address added.