Chronic Venous InsufficiencyPhase 3NCT01477281
Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
A Phase 3 study testing Daflon and Venaflon (Diosmin and Hesperidin) in people with Chronic Venous Insufficiency and Disease, run by Laboratório Teuto Brasileiro S/A.
Trial summary
The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency, Disease
- What is being tested?
- Daflon and Venaflon (Diosmin and Hesperidin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Aug 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years
- Women and men of childbearing age who agree to use acceptable contraception throughout the study.
- Be patient with chronic venous insufficiency of lower limbs varicose comDiagnostico clinical CEAP 0-3 by CEAP
- Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 4, as measured by visual analog scale
- Being the 7 days without any medication or treatment related to the venous system.
- Patients able to make proper use of medication
- Patients who consent to participate in the study by signing the Instrument of Consent.
Who cannot join
- Pregnant or breastfeeding women
- Women who are breastfeeding
- Women and men of childbearing age who do not accept to use acceptable contraception throughout the study
- Patients under 18 or over 65 years
- Patients with a history of hypersensitivity to any component of the formula
- Presence of signs and symptoms of different conditions of venous disease to justify the pain or swelling
Show all 16Show fewer
- Use of elastic compression in the last two weeks
- Venous obstruction of the lower limbs
- Patients who have previously used or Venaflon Daflon and did not benefit;
- Deep vein thrombosis in the last 6 months before entering the study;
- Use of diuretics in the last 4 weeks
- Previous venous surgery
- Patients with renal and liver failure
- Patients with gastritis or gastric ulcer
- Patients with blood clotting disorders
- Any condition which in the opinion of the physician researcher is significant and can make the patient unsuitable for study or you can place it under additional risk
About this study
Official title: A Clinical Multicenter, Phase III, Prospective, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.
Read the detailed description
"A clinical multicenter, phase III, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of Venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with Daflon."
- Conditions
- Chronic Venous Insufficiency, Disease
- Being tested
- Daflon, Venaflon (Diosmin and Hesperidin)
- Keywords
- chronic venous insufficiency, Daflon, Venaflon
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaflonDrug
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Venaflon (Diosmin and Hesperidin)Drug
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
| Study group | Role | What they receive |
|---|---|---|
| Venafon (Diosmin and Hesperidin) | Experimental | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). Receives: Drug: Daflon |
| Daflon | Active comparator | Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). Receives: Drug: Venaflon (Diosmin and Hesperidin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3
Measured: 30 days
Secondary outcomes (1)
Identify adverse events, as well as their frequency and causality related to study medication.
The secondary outcome measure will be to evaluate the tolerability of Venaflon in the symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório Teuto Brasileiro S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477281
- Sponsor's protocol ID
- E01-TEU-VEN-08-10
- Status last verified
- Nov 2011
- First submitted
- 19 Oct 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Multicenter, Phase III, Prospective, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
- ClinicalTrials.gov ID
- NCT01477281
- Acronym / sponsor ID
- E01-TEU-VEN-08-10
- Conditions
- Chronic Venous Insufficiency, Disease
- Keywords
- chronic venous insufficiency, Daflon, Venaflon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Laboratório Teuto Brasileiro S/AIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 22 Nov 2011 (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 objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.
Detailed description
"A clinical multicenter, phase III, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of Venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with Daflon."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venafon (Diosmin and Hesperidin) | Experimental | Drug: DaflonAdminister one tablet 2 times daily (oral), the main meals (lunch and dinner). |
| Daflon | Active comparator | Drug: Venaflon (Diosmin and Hesperidin)Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years
- Women and men of childbearing age who agree to use acceptable contraception throughout the study.
- Be patient with chronic venous insufficiency of lower limbs varicose comDiagnostico clinical CEAP 0-3 by CEAP
- Presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 4, as measured by visual analog scale
- Being the 7 days without any medication or treatment related to the venous system.
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding women
- Women who are breastfeeding
- Women and men of childbearing age who do not accept to use acceptable contraception throughout the study
- Patients under 18 or over 65 years
- Patients with a history of hypersensitivity to any component of the formula
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 |
|---|---|---|
| DaflonAdminister one tablet 2 times daily (oral), the main meals (lunch and dinner). | Drug | Venafon (Diosmin and Hesperidin) |
| Venaflon (Diosmin and Hesperidin)Administer one tablet 2 times daily (oral), the main meals (lunch and dinner). | Drug | Daflon |
Primary outcome
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
Time frame: 30 days
To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3
1 secondary outcome
Identify adverse events, as well as their frequency and causality related to study medication.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daflon and Venaflon (Diosmin and Hesperidin) in people with Chronic Venous Insufficiency and Disease, run by Laboratório Teuto Brasileiro S/A.
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 7 inclusion and 16 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 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3 (time frame: 30 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 22 Nov 2011.