Clinical trial NCT01477281: Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Venous Insufficiency
Disease
Keywords: chronic venous insufficiency
Daflon
Venaflon
Lead sponsor: Laboratório Teuto Brasileiro S/A
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

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

Primary outcomes:
measure: Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
timeFrame: 30 days
Secondary outcomes:
measure: Identify adverse events, as well as their frequency and causality related to study medication.
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
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