Clinical trial NCT00835822: Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Insufficiency
Keywords: Chronic Venous Insufficiency, Venocur Triplex®
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Statistika Consultoria Ltda
First posted: 2009-02-04
Enrollment: 216
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 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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 60 days
measure: Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness);
measure: Safety Assessment through the adverse events reports
Secondary outcomes:
measure: Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group
measure: Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ
timeFrame: 60 days
measure: The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale.
timeFrame: 60 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Botucatu
country: Brazil
state: Sao Paulo
city: Marilia
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
Study officials:
References: