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

Fundação Educacional Serra dos Órgãos

Status and phase

Completed

Phase 4

Conditions

Venous Insufficiency

Treatments

Drug: Diosmin

Drug: Diosmin / Hesperidin

Study type

Interventional

Funder types

Other

Identifiers

NCT03471910

DIVC-01-12-17

Details and patient eligibility

About

Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.

Full description

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 global physician's satisfaction.

Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:

Efficacy on venous symptoms : The VAS of 100 mm is rated by the patient from "0" = Absence of venous symptoms up to "100" = Maximal intensity of the venous symptoms. The VAS is completed by the patient at the investigator's office. This VAS globally assesses the venous symptomatology of the most symptomatic leg : Heavy legs, Painful legs, Tired legs, Sensation of swelling and/or tension in the legs).
Acceptability : Easiness to swallow assessed by a VAS of 100 mm rated by the patient from "0" = Very easy to swallow, up to "10" = Very difficult to swallow
Patient's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
Investigator's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
Tolerability (related adverse events)
Compliance : Accountability of treatments returned by the patient

The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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