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

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratório Teuto Brasileiro S/A

Criteria

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 throughout the study.

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

• Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 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 Criteria:

• Pregnant or breastfeeding women

• Women who are breastfeeding

• Women and men of childbearing age who do not accept to use acceptable contraception throughout 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 justify the 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 can make the patient unsuitable for study or you can place it under additional risk