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

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01477281
• Other study ID #: E01-TEU-VEN-08-10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 19, 2011
• Last updated: November 18, 2011
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2011
• Source: Laboratório Teuto Brasileiro S/A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Disease
• Venous Insufficiency

Intervention

Drug:
• Daflon
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
• Venaflon (Diosmin and Hesperidin)
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório Teuto Brasileiro S/A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes