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    Summary
    EudraCT Number:2017-004804-23
    Sponsor's Protocol Code Number:KCT13/2017–FLEBAVEN/SI
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-20
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2017-004804-23
    A.3Full title of the trial
    The efficacy and safety of a single dose Flebavena® (Diosmin) of 1000 mg per day in patients with chronic venous disease (LIGHTEN-UP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and safety of a single dose Flebavena® (Diosmin) of 1000 mg per day in patients with chronic venous disease (LIGHTEN-UP)
    A.3.2Name or abbreviated title of the trial where available
    LIGHTEN-UP
    A.4.1Sponsor's protocol code numberKCT13/2017–FLEBAVEN/SI
    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 SponsorKrka, d.d., Novo mesto
    B.1.3.4CountrySlovenia
    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 supportKrka, d.d., Novo mesto
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKrka d.d., Novo mesto
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressDunajska 65
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number0038641378577
    B.5.6E-mailvesna.bohinc-sever@krka.biz
    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 Yes
    D.2.1.1.1Trade name Flebaven®
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d., Novo mesto, Slovenija
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 nameFlebaven
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients diagnosed with primary chronic vein disease
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with primary chronic vein disease
    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
    The purpose of the study is to confirm the safety and efficacy of Flebaven 1000 mg once daily on:
    - reduction of leg pain,
    - reduction the feeling of heavy legs,
    - reduction of swelling of the legs and
    - improving the quality of life.














    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 20 to 70 years.
    - Patients diagnosed with primary chronic venous disease
    - Patients whose average leg pain is greater than or equal to 4 on the numerical scale (NS), which corresponds to the pain of moderate or severe intensity.
    - Patients classified on the most affected foot by the CEAP (Comprehensive Classification System for Chronic Venous Disorders) classification in the clinical grade C0s to C4s *.
    - Patients with a potential exclusion of another cause of leg pain (in the case of a discrepancy between the patient's subjective assessment of the severity of the symptoms and the physician's grade according to CEAP).
    - A Statement of Conscious and Free Consent signed.
    - Patient's ability to participate in a clinical trial.
    * 0-no visible or palpable signs of a venous illness; 1-teleangiectasia or reticular veins; 2-spine veins (varices); 3-swelling; 4-skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis)
    E.4Principal exclusion criteria
    Hypersensitivity to the active substance or to any of the excipients in the test product.
    • Patients classified on the most affected foot by the CEAP (Comprehensive Classification System for Chronic Venous Disorders) classification in the clinical grade C5s to C6s *.
    • Patients with concomitant nepharmacological treatment (sclerotherapy, surgical treatment of varicose veins, angioplasty, endovascular device) or patients with nepharmacological treatment within three months prior to inclusion.
    • Lower limb lymphaden, renal failure or decompensated cardiac failure, liver failure, gastrointestinal resection history, insufficient nutrition, malabsorption, active venous thrombosis, and significant chronic deep vein obstruction leading to venous claddication and important compression therapy, severe inflammatory disease, and others causes of lower limb pain.
    • Patients with concomitant treatment containing anti-inflammatory drugs (other than acetylsalicylic acid at an antiaggregation dose of less than 350 mg daily), systemic corticosteroids, immunosuppressive agents, and venoactive drugs.
    • Patients with concomitant treatment with opiates that were introduced or modified during the month prior to enrollment in the study.
    • Pregnant or nursing patients.
    • Patients who have recently given birth (6 months or less prior to inclusion).
    • Patients who, according to the researcher, will not be eligible for treatment.
    * 5-skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis) and hepatic venous ulceration; 6 skin changes (hyperpigmentation, dermatitis, lipodermatosclerosis) and active venous ulcer
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients in whom foot pain decreased by ≥ 30% (estimated on the numerical scale (NS) or the percentage of patients whose assessment of pain to NS did not exceed grade 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    [Timeframe: starting point, after 4 weeks, after 12 weeks].
    E.5.2Secondary end point(s)
    - Compare the difference in foot pain intensity from beginning to end of the study, estimated at NS [Timeframe: starting point, after 4 weeks, after 12 weeks].
    - Compare the difference in the feeling of difficulty from the beginning to the end of the study, estimated at NS [Time frame: starting point, after 4 weeks, after 12 weeks].
    - Compare the difference in the swelling intensity of the feet from the beginning to the end of the study, estimated at NS [Time frame: starting point, after 4 weeks, after 12 weeks].
    - Compare the difference in quality of life from the beginning to the end of the study, estimated using the SF-20 questionnaire (Quality of Life Questionnaire) [Timeframe: starting point, after 12 weeks].
    - Compare the difference in the severity of the disease during treatment based on the clinical global disease severity indicator (CGI-S) [Timeframe: starting point, after 4 weeks, after 12 weeks].
    - Comparison of the difference in the severity of the disease during treatment based on the clinical global disease improvement indicator (CGI-I) [Timeframe: after 4 weeks, after 12 weeks].
    - Subgroup of 25 patients: compare the difference in CVD visual signs (presence of varicose veins, swelling) from beginning to end treatment based on analysis of photos in patients with visible signs of KVB. [Timeframe: starting point, after 12 weeks].
    E.5.2.1Timepoint(s) of evaluation of this end point
    starting point, after 4 weeks, after 12 weeks
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned104
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months
    E.8.9.1In the Member State concerned days
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state500
    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)
    None
    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 Decision2018-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-06
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