Chronic Venous InsufficiencyPhase 3NCT01321619
Efficacy and Tolerability of the Use of Varicell Compared With Daflon
A Phase 3 study testing Daflon in people with Chronic Venous Insufficiency and Hemorrhoids, run by Vidfarma Indústria de Medicamentos Ltda. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency, Hemorrhoids
- What is being tested?
- Daflon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For both groups
- Patients who consent to participate in the study by signing the Instrument of Consent.
- Patients of all ethnic groups, of both sexes and aged at least 18 years old and maximum 65 years old;
- Being for seven days without any medication or treatment related to the venous system.
- Patients able to make proper use of medication;
- For Group V - Chronic Venous Insufficiency.
Show all 11Show fewer
- Presence of at least two symptoms (pain, heaviness and discomfort) in the lower limbs with scores greater than 3 measured by visual analogue scale;
- Clinical diagnosis of varicose veins rating of 0 to 3 by CEAP;
- In Group H - hemorrhoidal syndrome.
- Presence of at least two symptoms (pain in the anorectal evacuation to walk and / or at rest, feeling of anal discomfort (burning, itching, irritation) to evacuate to walk and / or at rest, bloating in the anorectal region, the presence and intensity of bleeding in the anorectal region, the presence and intensity of mucus in the anorectal region) with a score equal to or greater than 3 measured by visual analogue scale;
- Clinical Diagnosis of Hemorrhoids grade 1 and grade 2.
Who cannot join
- Pregnant or lactating;
- Patients aged less than 18 years old or older than 65 years old;
- Patients with a history of hypersensitivity to any component of the formula;
- Use of medications phlebotonics in the last 7 days;
- previous venous surgery;
- Patients with renal and liver failure.
Show all 11Show fewer
- Patients with gastritis or gastric ulcer;
- Patients with acute inflammatory diseases of the bowel, intestinal obstruction, appendicitis;
- Patients with ileus, stenosis, atony, undiagnosed abdominal symptoms, colonopathy inflammatory abdominal pain of unknown cause dehydration and loss of water and electrolytes and constipation;
- Patients with blood coagulation disorders;
- Any condition which in the opinion of the physician investigator is significant and can make the patient unsuitable for study or that might put you under additional risk.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Marcelina Hospital
São Paulo, São Paulo, 05016-081
Marcelo Calil, Investigator, 55 11 2070-6238, mcburihan@osite.com.br
Mônica Gonçalves, Coordenator, 55 11 2070-6238, monica_monica0001@hotmail.com
About this study
Official title: Study Clinical, Multicenter,Phase III,Prospective,Randomized,Comparative Double Blind/Double-dummy to Assess the Efficacy and Tolerability of the Use of Varicell in Reducing the Symptoms Caused by Chronic Venous Insufficiency and Hemorrhoidal Syndrome When Compared With Daflon
The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.
Read the detailed description
To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
- Conditions
- Chronic Venous Insufficiency, Hemorrhoids
- Being tested
- Daflon, Varicell placebo
- Keywords
- Chronic venous insufficiency, Hemorrhoidal syndrome, Varicell
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaflonDrug
Also called Diosmin
Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Varicell placeboDrug
Also called keratin, Circanetten.
Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Varicell | Experimental | Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days. Receives: Drug: Daflon |
| Placebo daflon (Drug D) | Experimental | Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days. Receives: Drug: Varicell placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
Measured: 30 days
Secondary outcomes (1)
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.
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 posted23 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vidfarma Indústria de Medicamentos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques Waisberg, Investigator, Principal investigator, ABC School of MedicineWalter Campos Júnior, Investigator, Principal investigator, Edmundo Vasconcelos Hospital TeacherLaércio Robles, Investigator, Principal investigator, Santa Marcelina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321619
- Sponsor's protocol ID
- VID-VAR-01/11
- Status last verified
- Jun 2011
- First submitted
- 15 Mar 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Clinical, Multicenter,Phase III,Prospective,Randomized,Comparative Double Blind/Double-dummy to Assess the Efficacy and Tolerability of the Use of Varicell in Reducing the Symptoms Caused by Chronic Venous Insufficiency and Hemorrhoidal Syndrome When Compared With Daflon
- ClinicalTrials.gov ID
- NCT01321619
- Acronym / sponsor ID
- VID-VAR-01/11
- Conditions
- Chronic Venous Insufficiency, Hemorrhoids
- Keywords
- Chronic venous insufficiency, Hemorrhoidal syndrome, Varicell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Vidfarma Indústria de Medicamentos Ltda.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Mar 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 purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.
Detailed description
To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varicell | Experimental | Drug: DaflonDrug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days. |
| Placebo daflon (Drug D) | Experimental | Drug: Varicell placeboDrug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For both groups
- Patients who consent to participate in the study by signing the Instrument of Consent.
- Patients of all ethnic groups, of both sexes and aged at least 18 years old and maximum 65 years old;
- Being for seven days without any medication or treatment related to the venous system.
- Patients able to make proper use of medication;
Key exclusion criteria (11 listed)
- Pregnant or lactating;
- Patients aged less than 18 years old or older than 65 years old;
- Patients with a history of hypersensitivity to any component of the formula;
- Use of medications phlebotonics in the last 7 days;
- previous venous surgery;
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 |
|---|---|---|
| DaflonAlso: DiosminDrug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days. | Drug | Varicell |
| Varicell placeboAlso: keratin, Circanetten.Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days. | Drug | Placebo daflon (Drug D) |
Primary outcome
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
Time frame: 30 days
Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
1 secondary outcome
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.
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 14 Jun 2011.
Related trials for Chronic Venous Insufficiency
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
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.
Jacques Waisberg, Investigator principal investigator
ABC School of Medicine
Walter Campos Júnior, Investigator principal investigator
Edmundo Vasconcelos Hospital Teacher
Laércio Robles, Investigator principal investigator
Santa Marcelina Hospital
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 Daflon in people with Chronic Venous Insufficiency and Hemorrhoids, run by Vidfarma Indústria de Medicamentos Ltda. 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 11 inclusion and 11 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 14 Jun 2011. 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 Marcelo Calil, Investigator (55 11 5549-6488, mcburihan@osite.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. (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 14 Jun 2011.