Venous InsufficiencyPhase 4NCT00835822
Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency
A Phase 4 study testing Venocur Triplex® in people with Venous Insufficiency, run by Abbott at 4 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Venocur Triplex®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 4 sitesBrazil
- Study dates
- May 2005to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Study site
Belo Horizonte, Minas Gerais
Study site
Botucatu, São Paulo
Study site
Marília, São Paulo
Study site
São Paulo, São Paulo
About this study
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
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
- Being tested
- Venocur Triplex®, placebo
- Keywords
- Chronic Venous Insufficiency, Venocur Triplex®
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venocur Triplex®Drug
Also called ABT-401, venopyronum, 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.
placeboDrug
Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Arm treated with Investigational product. Receives: Drug: Venocur Triplex® |
| B | Placebo comparator | Arm treated with placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 60 days
The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startMay 2005
- Primary completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistika Consultoria Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835822
- Sponsor's protocol ID
- BRAZ-03-003
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00835822
- Acronym / sponsor ID
- BRAZ-03-003
- Conditions
- Venous Insufficiency
- Keywords
- Chronic Venous Insufficiency, Venocur Triplex®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Statistika Consultoria Ltda
- Study start
- May 2005
- Primary completion
- Oct 2006 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Venocur Triplex®Arm treated with Investigational product. |
| B | Placebo comparator | Drug: placeboArm treated with placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venocur Triplex®Also: ABT-401, venopyronum, Venocur TriplexAdministered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages. | Drug | A |
| placeboAdministered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages. | Drug | B |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venocur Triplex® in people with Venous Insufficiency, run by Abbott at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.