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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Statistika Consultoria Ltda

Criteria

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.