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 个研究点开始时间: 2007年6月21日最近更新: 2012年3月19日

适应症

试验速览

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•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 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

发起方

HELP Pharmaceuticals S.A.