Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency

Launched by FUNDAÇÃO EDUCACIONAL SERRA DOS ÓRGÃOS · Mar 13, 2018

Keywords

ClinConnect Summary

The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.

The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:

* The oral acceptability,
* The tolerability,
* The global patient's satisfaction,
* The ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of both genders \>18 years old
• • Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
• • Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
• • Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
• • Subject has read, understood, dated and signed the informed consent form
• Exclusion Criteria:
• • Treatment by compression stocking within the 2 months before inclusion
• • Treatment by venotonics within the 2 months before inclusion
• • Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
• • Known allergy or hypersensitivity to any component of the study drug
• • Known clinically significant laboratory alterations
• • CEAP levels 4, 5 \& 6
• • Patient with venous disease requiring surgery / chemical endovenous sclerotherapy
• • Patient suffering from a painful pathology other than the venous pain in the lower limbs
• • Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion
• • Patient with alteration of general condition incompatible with his / her participation in the trial
• • Patient wishing to be pregnant in the 6 following months