E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of venous lymphatic insufficiency symptoms related to chronic venous disorders. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |