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

NCT ID: NCT01477281

Last Updated: 2011-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-08-31

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."

Conditions

Chronic Venous Insufficiency; Disease

Keywords

chronic venous insufficiency; Daflon; Venaflon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Venafon (Diosmin and Hesperidin)

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Group Type: EXPERIMENTAL

Daflon

Intervention Type: DRUG

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Daflon

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Group Type: ACTIVE_COMPARATOR

Venaflon (Diosmin and Hesperidin)

Intervention Type: DRUG

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Interventions

Daflon

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Intervention Type: DRUG

Venaflon (Diosmin and Hesperidin)

Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratório Teuto Brasileiro S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

E01-TEU-VEN-08-10

Identifier Type: -

Identifier Source: org_study_id