E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Venous Insufficiency |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066682 |
E.1.2 | Term | Chronic venous insufficiency |
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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 |
Primary study target is to investigate for any possible differences in efficacy and safety paremetrs between a generic version of MPFF diosmin & hesperidin (Pelethrocin®/HELP) and the original MPFF diosmin & hesperidin formulation marketed in Greece (Daflon®/Servier), in patients with chronic venous insufficiency (moderate & severe stages according to CEAP (Clinical, Etiological, Anatomical & Pathophysiological) classification). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are: 1-to investigate possible variations in the presented time for the improvement of symptoms and signs of the condition between generic and original versions of the combination of diosmin & hesperidin. 2-to investigate for potential differences in the quality of life between generic and original versions of the combination of diosmin & hesperidin. 3-to investigate for potential differences in the safety between generic and original versions of the combination of diosmin & hesperidin.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Patients who are able to read and comprehend the informed consent form 2- Patients who have signed the informed consent form 3- Patients diagnosed with chronic venous insufficiency of medium to serious stage (class C3+ according to CEAP), to whom diagnosis of the condition has been confirmed with the help of subjective methodology. Patients to be included must have AVP > 60mm Hg, at both lower limbs, whereas RT time should be < 10 sec. 4- External (ambulatory) patients, of both sexes, of ages between 35 and 75 inclusively. 5-Patients who, in the investigator's opinion, are othrwise healthy based on physical examination, medical history, and vital signs. 6- Patients who are wiling and able to attend study appointments within allowed time limits. |
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E.4 | Principal exclusion criteria |
1- Patients who have participated earlier (< 1 month) in another clinical trial of MPFF of combination of diosmine and esperidine 2- Patients who are taking prohibited recent or synchronious pharmaceutical prescription, meaning: metronidazol, CNS repressive medication, any diuretic preparation in the time span of last two weeks before the start of the trial. 3- Patients with other heart condition, neoplasmatic condition, diabetes and bone and junctures disorders. 4- Patients with ultrasound presence of recent (<12 months) venous thrombosis and/or medical history of suspicious venous thrombosis in the time span of the past 24 months. 5- Patients with medical history of serious allergy or hypersensitivity to preparation, or known hypersensitivity to the components of the study medication. 6- Female patients who are pregnant or are lactating. 7- Female patients with the ability to procreate and who are not using adequate contraception 8- Patients who, in the investigator’s opinion, are unlikely to comply with the clinical study protocol , or who are not appropriate for any other reasons
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is to investigate for any possible differences in efficacy between a generic version of MPFF diosmin & hesperidin (Pelethrocin®/HELP) and the original MPFF diosmin & hesperidin formulation marketed in Greece (Daflon®/Servier), in patients with chronic venous insufficiency (moderate & severe stages according to CEAP (Clinical, Etiological, Anatomical & Pathophysiological) classification). |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |