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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN53430167 |
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Date of registration:
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06/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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19/12/2013 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN53430167 |
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Study type:
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Interventional |
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Study design:
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International multicenter double-blind randomized parallel-group study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Russian Federation
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Serbia
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Contacts
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Name:
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Alexander
Kirienko |
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Address:
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Russian State Medical University
1, Ostrovityanova Street
117997
Moscow
Russian Federation |
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Telephone:
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- |
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Email:
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clinicaltrials@servier.com |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic venous insufficiency
Circulatory System
Venous insufficiency (chronic)(peripheral)
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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There are no secondary outcomes.
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Secondary ID(s)
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CL3-05682-107
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval was obtained before recruitment of the first participants
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/07/2014 |
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URL:
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