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

Last updated: June 18, 2018
Sponsor: Fundação Educacional Serra dos Órgãos
Overall Status: Completed

Phase

4

Condition

Deep Vein Thrombosis

Stasis Dermatitis

Claudication

Treatment

N/A

Clinical Study ID

NCT03471910
DIVC-01-12-17
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of both genders >18 years old

  • Patient presenting a C0 to C3 venous disease grade of the lower limbs, according tothe clinical component of the CEAP classification,

  • Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by aVAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomaticleg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painfullegs, Tired legs, Sensation of swelling and / or tension in the legs.

  • Premenopausal female subjects not pregnant or breastfeeding, in use of reliablecontraceptive

  • Subject has read, understood, dated and signed the informed consent form

Exclusion

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 usecontraception 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 lowerlimbs

  • Patient with history of venous thrombosis or thromboembolic disease within the 6months before inclusion

  • Patient with alteration of general condition incompatible with his / her participationin the trial

  • Patient wishing to be pregnant in the 6 following months

Study Design

Total Participants: 120
Study Start date:
June 20, 2017
Estimated Completion Date:
April 30, 2018

Study 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.

Connect with a study center

  • Centro Universitário Serra dos Órgãos - UNIFESO

    Teresópolis, RJ 25964004
    Brazil

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.