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

NCT01477281 | Unknown Phase 3 DMC

• 1 other identifier: E01-TEU-VEN-08-10
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/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.

Conditions

Chronic Venous Insufficiency; Disease

Keywords

chronic venous insufficiency; Daflon; Venaflon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify adverse events, as well as their frequency and causality related to study medication.

  30 days

Study Arms (2)

Venafon (Diosmin and Hesperidin)

EXPERIMENTAL

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

Drug: Daflon

Daflon

ACTIVE COMPARATOR

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

Drug: Venaflon (Diosmin and Hesperidin)

Interventions

Daflon DRUG

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

Venafon (Diosmin and Hesperidin)

Venaflon (Diosmin and Hesperidin) DRUG

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

Daflon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratório Teuto Brasileiro S/A: lead

MeSH Terms

Conditions

Disease

Interventions

Diosmin; Hesperidin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 22, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 22, 2011

Record last verified: 2011-11