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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
Laboratório Teuto Brasileiro S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring chronic venous insufficiency, Daflon, Venaflon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 19, 2011
    Last Updated
    November 18, 2011
    Sponsor
    Laboratório Teuto Brasileiro S/A
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    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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