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 |
| Protocol serial number | CL3-05682-107 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Scientific
Russian State Medical University
1, Ostrovityanova Street
Moscow
117997
Russian Federation
| clinicaltrials@servier.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicenter double-blind randomized parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Daflon/Detralex |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
There are no secondary outcomes. |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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
117997
Russian Federation
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
