Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
Primary Purpose
Chronic Venous Insufficiency, Disease
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Daflon
Venaflon (Diosmin and Hesperidin)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring chronic venous insufficiency, Daflon, Venaflon
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Venafon (Diosmin and Hesperidin)
Daflon
Arm Description
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01477281
First Posted
October 19, 2011
Last Updated
November 18, 2011
Sponsor
Laboratório Teuto Brasileiro S/A
1. Study Identification
Unique Protocol Identification Number
NCT01477281
Brief Title
Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratório Teuto Brasileiro S/A
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, Disease
Keywords
chronic venous insufficiency, Daflon, Venaflon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venafon (Diosmin and Hesperidin)
Arm Type
Experimental
Arm Description
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Arm Title
Daflon
Arm Type
Active Comparator
Arm Description
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Intervention Type
Drug
Intervention Name(s)
Daflon
Intervention Description
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Intervention Type
Drug
Intervention Name(s)
Venaflon (Diosmin and Hesperidin)
Intervention Description
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
Primary Outcome Measure Information:
Title
Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3
Description
To evaluate the efficacy of Venaflon compared with Daflon in the improves of symptomatic treatment of chronic venous insufficiency with classification CEAP 0-3
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Identify adverse events, as well as their frequency and causality related to study medication.
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
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