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

Phase 3

• Conditions: Chronic Venous Insufficiency; Disease
• Interventions: Drug: Daflon; Drug: Venaflon (Diosmin and Hesperidin)

• Registration Number: NCT01477281
• Lead Sponsor: Laboratório Teuto Brasileiro S/A

Brief 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.

Detailed 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."

Study Timeline

• Study First Submitted: 2011-10-19
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-18
• Last Update Submitted: 2011-11-18
• Study First Posted: 2011-11-22
• Last Update Posted: 2011-11-22
• Study Start: 2012-02
• Primary Completion: 2012-07
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venafon (Diosmin and Hesperidin)	Daflon	Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Daflon	Venaflon (Diosmin and Hesperidin)	Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Primary Outcome Measures

Name	Time	Method
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3	30 days	To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3

Secondary Outcome Measures

Name	Time	Method
Identify adverse events, as well as their frequency and causality related to study medication.	30 days	The secondary outcome measure will be to evaluate the tolerability of Venaflon in the symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3.