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

Abbott

Status and phase

Completed

Phase 4

Conditions

Venous Insufficiency

Treatments

Drug: Venocur Triplex®

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00835822

BRAZ-03-003

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.