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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-003633-28
    Sponsor's Protocol Code Number:CL3-05682-109
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-003633-28
    A.3Full title of the trial
    Clinical non-inferiority study between Micronized purified
    flavonoid fraction 1000 mg, one chewable tablet per day and
    Micronized Purified Flavonoid Fraction 500 mg, 2 tablets
    daily after eight weeks of treatment in patients suffering from
    symptomatic Chronic Venous Disease (CVD).
    International, multicenter, double-blind, randomized, parallel
    group study
    Klinische Nichtunterlegenheitsstudie von gereinigter, mikronisierter Flavonoidfraktion (MPFF) 1000 mg, eine Kautablette pro Tag, und gereinigter, mikronisierter Flavonoidfraktion (MPFF) 500 mg, 2 Tabletten pro Tag nach acht Wochen Behandlung bei Patienten mit symptomatischer chronisch-venöser Erkrankung (CVD).
    Internationale, multizentrische, doppelblinde, randomisierte Parallelgruppenstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical non-inferiority study between Micronized purified
    flavonoid fraction 1000 mg, one chewable tablet per day and
    Micronized Purified Flavonoid Fraction 500 mg, 2 tablets
    daily after eight weeks of treatment in patients suffering from
    symptomatic Chronic Venous Disease (CVD).
    Klinische Nichtunterlegenheitsstudie von gereinigter, mikronisierter Flavonoidfraktion (MPFF) 1000 mg, eine Kautablette pro Tag, und gereinigter, mikronisierter Flavonoidfraktion (MPFF) 500 mg, 2 Tabletten pro Tag nach acht Wochen Behandlung bei Patienten mit symptomatischer chronisch-venöser Erkrankung (CVD).
    A.3.2Name or abbreviated title of the trial where available
    Micronized purified flavonoid fraction 1000 mg, one chewable tablet per day - CHEWY
    A.4.1Sponsor's protocol code numberCL3-05682-109
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1209-6049
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recherches Internationales SERVIER (I.R.I.S.)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health, LLC
    B.5.2Functional name of contact pointContract Research Organization
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville, North Carolina
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.6E-maillaraine.shearer@syneoshealth.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMicronised purified flavonoid fraction
    D.3.2Product code S05682
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMicronized purified flavonoid fraction
    D.3.9.2Current sponsor codeS05682
    D.3.9.3Other descriptive nameMICRONISED PURIFIED FLAVONOIC FRACTION
    D.3.9.4EV Substance CodeSUB168332
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Daflon
    D.2.1.1.2Name of the Marketing Authorisation holderLES LABORATOIRES SERVIER INDUSTRIE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMicronized purified flavoinoid fraction
    D.3.2Product code S05682
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMicronized purified flavonoid fraction
    D.3.9.2Current sponsor codeS05682
    D.3.9.3Other descriptive nameMICRONISED PURIFIED FLAVONOIC FRACTION
    D.3.9.4EV Substance CodeSUB168332
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboChewable tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    symptomatic Chronic Venous Disease (CVD).
    E.1.1.1Medical condition in easily understood language
    symptomatic Chronic Venous Disease (CVD).
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066682
    E.1.2Term Chronic venous insufficiency
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to demonstrate the clinical non-inferiority of efficacy between micronised purified
    flavonoid fraction (MPFF) 1000 mg, 1 chewable tablet, and MPFF 500 mg, 2 tablets, in
    improving lower limb discomfort assessed by a 10 cm electronic visual analogue scale (eVAS) after 8 weeks
    of treatment in patients suffering from CVD.
    E.2.2Secondary objectives of the trial
    to determine the evolution of efficacy during the study according to each symptom (leg pain and leg heaviness assessed by 10 cm eVAS), the quality of life evolution in both groups (assessed by electronic Chronic Venous Insufficiency quality of life Questionnaire), the safety profile, and the acceptability of MPFF 1000 mg chewable tablet as compared to MPFF 500 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patient 20 to 75 years old inclusive,
    - male or female,
    - 18 kg/m² ≤ BMI ≤ 35 kg/m²,
    - suffering from primary chronic venous disease, with lower limb discomfort superior or equal to
    4 cm on eVAS,
    - clinical class C0s to C4s on the most affected leg, according to the Clinical Etiological Anatomic
    Pathophysiologic (CEAP) classification.
    E.4Principal exclusion criteria
    - unlikely to co-operate in the study,
    - unable to fill in a questionnaire or a ePRO by himself,
    - severe locomotor disability,
    - patient who had a total or partial leg/foot amputation,
    - pregnancy, breastfeeding, or woman of child bearing potential without an effective contraceptive
    method.
    E.5 End points
    E.5.1Primary end point(s)
    Lower limb discomfort assessed by eVAS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Selection visit, W000, W004, W008
    E.5.2Secondary end point(s)
    - Leg pain assessed by eVAS
    - Leg heaviness assessed by eVAS
    - Quality of life assessed by eCIVIQ
    - Adverse events, vital signs and overall acceptability
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Leg pain assessed by eVAS: Selection visit, W000, W004, W008
    - Leg heaviness assessed by eVAS: Selection visit, W000, W004, W008
    - Quality of life assessed by eCIVIQ: Selection visit, W000, W004, W008
    - Adverse events and vital signs: all over the study
    Overall acceptability: W008
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Brazil
    Hungary
    Romania
    Russian Federation
    Thailand
    Turkey
    Vietnam
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 524
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 570
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the discontinuation of the IMP the participants' treatment is left to the physician's discretion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-07
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