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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Laboratório Teuto Brasileiro S/A.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01477281
First received: October 19, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Chronic Venous Insufficiency
Disease
Drug: Daflon
Drug: Venaflon (Diosmin and Hesperidin)
Phase 3

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

Further study details as provided by Laboratório Teuto Brasileiro S/A:

Primary Outcome Measures:
  • Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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:
  • Identify adverse events, as well as their frequency and causality related to study medication. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 82
Study Start Date: February 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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."

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier: NCT01477281     History of Changes
Other Study ID Numbers: E01-TEU-VEN-08-10
Study First Received: October 19, 2011
Last Updated: November 18, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratório Teuto Brasileiro S/A:
chronic venous insufficiency
Daflon
Venaflon

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014