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

NCT ID: NCT00835822

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31

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.

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Arm treated with Investigational product.

Group Type: EXPERIMENTAL

Venocur Triplex®

Intervention Type: DRUG

Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.

B

Arm treated with placebo.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ABT-401; venopyronum; Venocur Triplex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Statistika Consultoria Ltda

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Laboratórios do Brasil Ltda.

Locations

Belo Horizonte, Minas Gerais, Brazil

Botucatu, São Paulo, Brazil

Marília, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

BRAZ-03-003

Identifier Type: -

Identifier Source: org_study_id