Venous InsufficiencyPhase 3NCT01110512
Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
A Phase 3 study testing Flavonid and Daflon in people with Venous Insufficiency, run by Azidus Brasil at 1 site in Brazil.
Trial summary
It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Flavonid and Daflon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Mar 2011
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who agree to the terms described in IC;
- Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
- Subjects with CVI ranked 3 to 5, according to CEAP scale;
- Patients complaining of pain and swelling in the lower limbs secondary to IVC;
- Subjects with good mental health that can respond adequately to the study questionnaires;
- Subjects who agree to make any return visits for evaluation;
Who cannot join
- Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
- Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
- Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
- Pregnant or nursing women;
- Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
- Participation in clinical trials in the twelve months preceding the study;
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- Patients with serious illnesses and uncontrolled that need multidrug treatment;
- Patients on diuretics of any kind, regardless of pathology (hypertension, renal or liver disease);
- Values of laboratory tests appropriate security; the Hemoglobin <10 mg / mL the creatinine> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
- past medical history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
Alexandre Frederico, Psysician, 55 19 3829-3822, alexandre@lalclinica.com.br
About this study
It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.
- Conditions
- Venous Insufficiency
- Being tested
- Flavonid, Daflon
- Keywords
- Improvement of CVI parameters
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonidDrug
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day.
DaflonDrug
Diosmin (450 mg) + hesperidin (50 mg)
1 tablet, 2 times per day
| Study group | Role | What they receive |
|---|---|---|
| Flavonid | Experimental | Not described Receives: Drug: Flavonid |
| Daflon | Active comparator | Not described Receives: Drug: Daflon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the parameters of CVI, such as edema of lower members.
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).
Measured: 90 days.
Secondary outcomes (1)
Improvement of the parameters of CVI.
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5). Assessment of improvement of signs and symptoms secondary to IVC, which are:
- paresthesia (tingling);
- Itching;
- Pain;
- cramps at night;
- Discomfort functional;
- Heaviness.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandre Frederico, Doctor, Principal investigator, LAL Clinical Reseach e Development Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110512
- Sponsor's protocol ID
- FLANEO0210
- Other IDs
- Version 3
- Status last verified
- Apr 2010
- First submitted
- 19 Apr 2010
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
- ClinicalTrials.gov ID
- NCT01110512
- Acronym / sponsor ID
- FLANEO0210
- Conditions
- Venous Insufficiency
- Keywords
- Improvement of CVI parameters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 26 Apr 2010 (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.
It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavonid | Experimental | Drug: Flavonid |
| Daflon | Active comparator | Drug: Daflon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who agree to the terms described in IC;
- Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
- Subjects with CVI ranked 3 to 5, according to CEAP scale;
- Patients complaining of pain and swelling in the lower limbs secondary to IVC;
- Subjects with good mental health that can respond adequately to the study questionnaires;
Key exclusion criteria (10 listed)
- Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
- Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
- Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
- Pregnant or nursing women;
- Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
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 |
|---|---|---|
| FlavonidDiosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day. | Drug | Flavonid |
| DaflonDiosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day | Drug | Daflon |
Primary outcome
Improvement of the parameters of CVI, such as edema of lower members.
Time frame: 90 days.
There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).
1 secondary outcome
Improvement of the parameters of CVI.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
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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.
Alexandre Frederico, Doctor principal investigator
LAL Clinical Reseach e Development Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flavonid and Daflon in people with Venous Insufficiency, run by Azidus Brasil at 1 site 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, Psysician (55 19 3829-3822, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the parameters of CVI, such as edema of lower members. (time frame: 90 days.). 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 27 Oct 2010.