NCT00835822

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

1.4 years

First QC Date

February 2, 2009

Last Update Submit

February 3, 2009

Conditions

Venous Insufficiency

Keywords

Chronic Venous Insufficiency, Venocur Triplex®

Outcome Measures

Primary Outcomes (3)

  • 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)

    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

Secondary Outcomes (3)

  • 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

    60 days

  • The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale.

    60 days

Study Arms (2)

A

EXPERIMENTAL

Arm treated with Investigational product.

Drug: Venocur Triplex®

B

PLACEBO COMPARATOR

Arm treated with placebo.

Drug: placebo

Interventions

Venocur Triplex®DRUG

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

Also known as: ABT-401, venopyronum, Venocur Triplex
A
placeboDRUG

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Belo Horizonte, Minas Gerais, Brazil

Location

Unknown Facility

Botucatu, São Paulo, Brazil

Location

Unknown Facility

Marília, São Paulo, Brazil

Location

Unknown Facility

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

phenopyrazone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

May 1, 2005

Primary Completion

October 1, 2006

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

BR(4)