Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency

Multicenter, Prospective, Randomized, Double-Blind Study to Assess the Therapeutic Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency

The purpose of this study is to assess the therapeutic efficacy and safety of Venocur Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated between CEAP 2 and 4, in comparison to a Placebo group.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency
• Intervention / Treatment: Drug: Venocur Triplex®; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil
    • Marilia, Sao Paulo, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC)
• Patients of both sexes, aged above 18 years and below 65 years
• Presence of uni- or bilateral varicose veins with CVI, in both sexes
• The patient's CVI is rated between functional classes CEAP 2 and 4
• Present at least one symptom of CVI prior to the study - leg pains, cramps, fatigue, heavy legs sensation.

Exclusion Criteria:

• If female, the patient has circulatory disorders exclusively during the pre-menstrual period
• If the patient is pregnant or breastfeeding
• The patient has received anticoagulants less than 15 days before study start
• The patient has used steroids or anti-inflammatory drugs less than 8 days before study start
• The patient has received radio or chemotherapy less than 7 days before study start
• The patient has used diuretics, phlebotrophic and venoactive drugs over the past 8 days before enrollment in the study
• The patient has used compression stockings less than 8 days before study start
• Trauma or surgical treatment over the past 30 days before study start
• Prior surgical treatment related to CVI (past 12 months for surgery and past 6 months for sclerotherapy)
• Immobilization of lower limbs over the past 6 months
• Known allergy to the product's ingredients
• Presence of chronic inflammatory diseases (rheumatoid arthritis, for instance), severe chronic infectious diseases (AIDS, tuberculosis, hanseniasis, etc.)
• The patient has suffered from phlebitis or deep venous thrombosis in the past 6 months before the study
• Fibrous lymphedema, primary or secondary lymphedema and lipoedema;
• Concomitant erysipelas
• Active fungal infections of the lower limbs
• Peripheral arteries disease, cerebrovascular or coronary disease
• Severe systemic conditions (heart failure, liver, pulmonary or kidney failure, active neoplastic disease, severe arterial hypertension, uncontrolled diabetes, among others), over the past 6 months before study start
• Hematocrit: < 32.0 mL RBC/dL for women and < 36.0 mL RBC/dL for men
• Hemoglobin: < 11.0 mL g/dL for women and < 12.0 mL g/dL for men;
• Total protein and fractions: Total protein < 6.4 g/dL, Albumin < 4.0 g/dL, Globulin < 1g/dL and Albumin/Globulin < 0.9%
• Serum creatinine: > 1.0 mg/dL for women and > 1.2 mg/dL for men or if patient in dialysis
• Aminotranferases (SGOT/AST and/or SGPT/ALT) more than twice the upper normal limit
• Participation in study with similar objectives over the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Arm treated with Investigational product.	Drug: Venocur Triplex®; Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.; Other Names: ABT-401; venopyronum; Venocur Triplex
Placebo Comparator: B; Arm treated with placebo.	Drug: placebo; Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of the score of the CVI symptoms, based on symptoms as leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness)	60 days
Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness);
Safety Assessment through the adverse events reports

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group
Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ	60 days
The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale.	60 days

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Statistika Consultoria Ltda

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Chronic Venous Insufficiency, Venocur Triplex®
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: BRAZ-03-003