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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00835822
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 4, 2009
Sponsor:
Collaborator:
Statistika Consultoria Ltda
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 4, 2009
Last Update Posted Date February 4, 2009
Study Start Date  ICMJE May 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
  • 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 ]
  • Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness);
  • Safety Assessment through the adverse events reports
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
  • Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group
  • Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ [ Time Frame: 60 days ]
  • The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale. [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Venous Insufficiency
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: A
    Arm treated with Investigational product.
    Intervention: Drug: Venocur Triplex®
  • Placebo Comparator: B
    Arm treated with placebo.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2009)
216
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835822
Other Study ID Numbers  ICMJE BRAZ-03-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suely Kumagai Inoue, Abbott Laboratórios do Brasil Ltda.
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Statistika Consultoria Ltda
Investigators  ICMJE Not Provided
PRS Account Abbott
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP