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Status:

COMPLETED

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

Lead Sponsor:

Abbott

Collaborating Sponsors:

Statistika Consultoria Ltda

Conditions:

Venous Insufficiency

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

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, i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

216 Patients enrolled

Trial Details

Trial ID

NCT00835822

Start Date

May 1 2005

Last Update

February 4 2009

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Belo Horizonte, Minas Gerais, Brazil

2

Botucatu, São Paulo, Brazil

3

Marília, São Paulo, Brazil

4

São Paulo, São Paulo, Brazil