A multicenter, randomized, parallel patients’ group, comparative clinical trial for the assessement of efficacy and safety of Pelethrocin®/HELP 500 mg (generic diosmin & hesperidin MPFF) versus Daflon®/Servier 500 mg (original diosmin & hesperidin MPFF) in the treatment of chronic venous insufficiency patients (a therapeutic equivalence trial).

HELP Pharmaceuticals S.A.0 sitesJune 21, 2007

Overview

No summary available.

Registry

who.int

Start Date

June 21, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

HELP Pharmaceuticals S.A.

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•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