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

Phase 4

Completed

• Conditions: Venous Insufficiency
• Interventions: Drug: Venocur Triplex®; Drug: placebo

• Registration Number: NCT00835822
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-10
• Status Verified: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-03
• Last Update Submitted: 2009-02-03
• Study First Posted: 2009-02-04
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Venocur Triplex®	Arm treated with Investigational product.
B	placebo	Arm treated with placebo.

Primary Outcome Measures

Name	Time	Method
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

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