Chronic Venous Insufficiency MedDRA version: 9.1 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency
Conditions
Interventions
Trade Name: Pelethrocin
Product Name: Pelethrocin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DIOSMIN
CAS Number: 520274
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
HELP Pharmaceuticals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: 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. ;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). | — |
Countries
Greece
Outcome results
None listed