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).

• Conditions: Chronic Venous Insufficiency; MedDRA version: 9.1Level: LLTClassification code 10066682Term: Chronic venous insufficiency

• Registration Number: EUCTR2007-001947-23-GR
• Lead Sponsor: HELP Pharmaceuticals S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified