Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency - Full Text View

Purpose

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.

Condition	Intervention	Phase
Venous Insufficiency	Drug: Venocur Triplex® Drug: placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fatigue

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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) [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness); [ Designated as safety issue: No ]
Safety Assessment through the adverse events reports [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group [ Designated as safety issue: No ]
Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ [ Time Frame: 60 days ] [ Designated as safety issue: No ]
The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment:	216
Study Start Date:	May 2005
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Arm treated with Investigational product.	Drug: 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. Other Names: ABT-401 venopyronum Venocur Triplex
Placebo Comparator: B Arm treated with placebo.	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. Other Name: placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835822

Locations

Brazil

Belo Horizonte, Minas Gerais, Brazil

Botucatu, Sao Paulo, Brazil

Marilia, Sao Paulo, Brazil

Sao Paulo, Brazil

Sponsors and Collaborators

Abbott

Statistika Consultoria Ltda

More Information

No publications provided

Responsible Party:	Suely Kumagai Inoue, Abbott Laboratórios do Brasil Ltda.
ClinicalTrials.gov Identifier:	NCT00835822 History of Changes
Other Study ID Numbers:	BRAZ-03-003
Study First Received:	February 2, 2009
Last Updated:	February 3, 2009
Health Authority:	Brazil: Ethics Committee Brazil: National Health Surveillance Agency

Keywords provided by Abbott:

Chronic Venous Insufficiency, Venocur Triplex®

Additional relevant MeSH terms:

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013