A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months

SunWave Pharma0 sites120 target enrollmentNovember 2016

ConditionsChronic Venous Insufficiency

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Venous Insufficiency
Sponsor: SunWave Pharma
Enrollment: 120
Primary Endpoint: Change from baseline in limb volume determination at day 180 (water displacement method)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.

Detailed Description

A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

June 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SunWave Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients, male or females aged 18 to 75 years old
•Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
•Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
•Willing and able to give written informed consent prior to participation in the trial
•Patients expected to be compliant with the study treatment

Exclusion Criteria

•Known allergy to the product's ingredients
•Pregnancy or breastfeeding
•Patient is involved in any other clinical trial
•Deep vein thrombosis
•Stasis dermatitis
•The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
•Open ulcers or lower extremity amputation
•Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
•Patient presenting permanent oedema,
•Patient with a history of lower limbs trauma responsible for sequel pains

Outcomes

Primary Outcomes

Change from baseline in limb volume determination at day 180 (water displacement method)

Time Frame: 180 days

Secondary Outcomes

Change from pre-treatment (baseline) in the calf circumference on treatment day 180(180 days)
Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180(180 days)
Change from pre-treatment (baseline) in the calf circumference on treatment day 30(30 days)
Global assessment of tolerability by the investigator at day 180(180 days)
Change from baseline in limb volume determination at day 90 (water displacement method)(90 days)
Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90(90 days)
Global assessment of efficacy by the investigator at day 180(180 days)
Adverse events(180 days)
Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)(180 days)