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    Summary
    EudraCT Number:2009-014681-25
    Sponsor's Protocol Code Number:DC 0982 GE 203 1B
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-22
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2009-014681-25
    A.3Full title of the trial
    Pharmacodynamic and clinical assessment of DC 982 GE (2,4 or 6 capsules per day) in patients with chronic venous disorders :
    randomised, placebo-controlled, dose effect, double blind, parallel group study
    A.4.1Sponsor's protocol code numberDC 0982 GE 203 1B
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT-IRPF-IDPF
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CYCLO 3 FORT 150 mg/150 mg/100 mg hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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 nameCYCLO 3 FORT
    D.3.2Product code DC982GE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRuscus extract
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHesperidin methyl chalcone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAscorbic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeCombination of 3 active substances: - Ruscus: Herbal. - Hesperidin methyl chalcone: herbal and hemisynthetic. - Ascorbic acid: chemical
    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 placeboCapsule, hard
    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
    Treatment of venous lymphatic insufficiency symptoms related to chronic venous disorders.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10066682
    E.1.2Term Chronic venous insufficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the dose effect of DC982 GE based on pharmacodynamic parameters after 28 days of treatment.

    Duplex scan measurements and venous reflux hemodynamic of great saphenous vein (GSV) criteria, on a segment ranging from 7 cm to 13 cm upper the femorotibial articular space of the knee join :

    - Peak reflux velocity in cm/s
    - Vein diameter in mm
    - Reflux duration in second
    E.2.2Secondary objectives of the trial
    - To assess the dose effect of DC982 GE based on clinical evaluation of symptoms after 28 days of treatment
    - To assess the safety and tolerance of DC982 GE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Non-menopausal, non sterile women aged of more than 18 years,
    - Primary chronic venous disorder (CVD)
    Stage C1.2,S, or C2,S of the advanced CEAP clinical classification
    Stable within the 6 months before the inclusion visit
    Symptomatic at inclusion with a minimal score of 6 on VAS (0 to 10 cm) for at least one of the following symptoms :
    ­ -- Pain / heaviness
    ­ -- Paraesthesia/cramps
    ­ -- Feeling of swelling
    - Incompetence of Great Saphenous Vein characterised by a reverse flow after calf compression release measured in the lower third of the thigh (7 cm to 13 cm upper the femorotibial joint space of the knee) longer or equal than 0.5 second with duplex scanning in standing position
    - Agreeing not to use products with the same indication during the study,
    - Agreeing to sign a written Informed Consent Form,
    - Accepting to attend the planned visits at the investigational centre and to comply with all trial requirement,
    - If required by national regulation, registered with a social security or health insurance system,
    - For this woman of childbearing potential:
    ­ Regular menstrual cycle of 28 days ± 3,
    ­ Inclusion to be performed in the first period of the cycle (1st to 14th days)
    ­ Negative urine pregnancy test at inclusion,
    ­ Use an efficient method of contraception (implants, injectables, combined oral contraceptives, some intra-uterine devices) for at least 2 months before the study, during the study and one month after the end of the study.
    E.4Principal exclusion criteria
    Related to the pathology
    - Superficial and or deep venous thrombosis detected with the duplex scan
    - Secondary venous insufficiency including :
    a. history of deep venous thrombosis,
    b. post thrombotic syndrome,
    c. venous dysplasia,
    d. compressive syndrome
    - Primary venous reflux of deep veins,
    - History of venous stripping or phlebectomy
    - Any sclerosing injections within the 6 months before the inclusion,
    - Oedema from any aetiology including : chronic heart failure, liver disease, renal disease, lymphatic pathology (Stemmer sign), iatrogenic (calcium blockers ...)...,
    - Paresthesia of the lower limbs from other origin,
    - Any pain of the lower limbs in relationship with another pathology (e.g. arthrosis, neuropathy, peripheral vascular disease ...).
    - Acute or chronic systemic disease or disorder liable to interfere with study implementation and/or study parameter assessment

    Related to treatments
    - Hypersensitivity, allergy or intolerance to Ruscus extract, Hesperidin Methyl Chalcone , Ascorbic Acid, sunset yellow (E110) or any component of the formulation,
    - Intake of venotonic treatments, triptans, diuretics, calcium blockers, beta blockers, ACE inhibitors, and/or vasodilators and/or vasoconstrictors, within the month before the inclusion visit,
    - NSAID, corticosteroids, ergotamine, dihydroergotamine or any ergot alkaloids, vitamin C, nutraceutical or phytotherapy products with potential venotonic effect intake within the 2 weeks before the inclusion visit
    - Bandages or compression within the 2 weeks before the inclusion visit.

    Related to the population
    - BMI superior or equal to 30
    - Underlying arteriopathy
    - History of pulmonary embolism
    - Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them at risk or is likely to modify their handling of the study drug,
    - Female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
    - Participation to an other clinical trial in the previous month or during the study,
    - Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
    - Patient who, in the judgement of the investigator, is not likely to be compliant during the study,
    - Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    Primary criteria:

    Hemodynamic parameters

    Venous parameters variation by duplex scan measurement at D28.
    The assessment will be performed on both legs at the same localization and will concern the Great Saphenous Veins (GSV), which usually run from ankle to groin. The measurements will be carried out in the lower third of the thigh (7 cm to 13 cm upper the femorotibial articular space of the knee join).
    These veins will be investigated using the duplex scan in order to collect the following parameters:
    - Peak reflux velocity in cm/s (PRV)
    - Venous diameter in mm
    - Duration of reflux in s
    The PRV will be considered as the main criterion of interest.
    Measurements have to be done for each evaluation in a standing position and in the same room temperature condition (20 to 24°C).
    In addition, for the inclusion evaluation (V2) and for the end of the study visit evaluation (V3), measurements have to be done:
    - in the first period of the menstrual cycle (1st to 14th days),
    - in the afternoon, always at the same time (more or less 1 hour) between 4 and 8 pm.

    Reflux will be elicited by manual compression of the calf with subsequent sudden release.
    The main evaluation will be focused on the GSV of the most affected leg (higher PRV).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 Information not present in EudraCT
    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
    Last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Non menopausal and non sterile women
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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)
    0
    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 Decision2010-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-09
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