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

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

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

Study Overview

• Status: Unknown
• Conditions: Disease; Chronic Venous Insufficiency
• Intervention / Treatment: Drug: Daflon; Drug: Venaflon (Diosmin and Hesperidin)

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venafon (Diosmin and Hesperidin); Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).	Drug: Daflon; Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Active Comparator: Daflon; Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).	Drug: Venaflon (Diosmin and Hesperidin); Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify adverse events, as well as their frequency and causality related to study medication.	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.	30 days

Collaborators and Investigators

• Sponsor: Laboratório Teuto Brasileiro S/A

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 18, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: chronic venous insufficiency; Daflon; Venaflon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: E01-TEU-VEN-08-10