Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon

Last updated: November 18, 2011
Sponsor: Laboratório Teuto Brasileiro S/A
Overall Status: Trial Status Unknown

Phase

3

Condition

Stasis Dermatitis

Vascular Diseases

Venous Thrombosis

Treatment

N/A

Clinical Study ID

NCT01477281
E01-TEU-VEN-08-10
  • Ages 18-65
  • All Genders

Study Summary

The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years

  • Women and men of childbearing age who agree to use acceptable contraception throughoutthe study.

  • Be patient with chronic venous insufficiency of lower limbs varicose comDiagnosticoclinical CEAP 0-3 by CEAP

  • Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat andburning sensation in the legs) in the lower limbs, with a score equal to or greaterthan 4, as measured by visual analog scale

  • Being the 7 days without any medication or treatment related to the venous system.

  • Patients able to make proper use of medication

  • Patients who consent to participate in the study by signing the Instrument of Consent.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding women

  • Women who are breastfeeding

  • Women and men of childbearing age who do not accept to use acceptable contraceptionthroughout the study

  • Patients under 18 or over 65 years

  • Patients with a history of hypersensitivity to any component of the formula

  • Presence of signs and symptoms of different conditions of venous disease to justifythe pain or swelling

  • Use of elastic compression in the last two weeks

  • Venous obstruction of the lower limbs

  • Patients who have previously used or Venaflon Daflon and did not benefit;

  • Deep vein thrombosis in the last 6 months before entering the study;

  • Use of diuretics in the last 4 weeks

  • Previous venous surgery

  • Patients with renal and liver failure

  • Patients with gastritis or gastric ulcer

  • Patients with blood clotting disorders

  • Any condition which in the opinion of the physician researcher is significant and canmake the patient unsuitable for study or you can place it under additional risk

Study Design

Total Participants: 82
Study Start date:
February 01, 2012
Estimated Completion Date:
August 31, 2012

Study Description

"A clinical multicenter, phase III, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of Venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with Daflon."