CClinicalTrials.gg
Status unknownNCT01477281Updated Nov 22, 2011

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 interventional study of Daflon and Venaflon (Diosmin and Hesperidin) in Chronic Venous Insufficiency and Disease, sponsored by Laboratório Teuto Brasileiro S/A. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-11-22.

Sponsored by Laboratório Teuto Brasileiro S/A · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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."

02

Conditions studied

  • Chronic Venous Insufficiency
  • Disease

Browse trials for

Keywords

  • chronic venous insufficiency
  • Daflon
  • Venaflon
03

In context

Venous Insufficiency

189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.

This study's planned enrollment of 82 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.

Browse Venous Insufficiency studies →

Lead sponsor

Laboratório Teuto Brasileiro S/A is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Venafon (Diosmin and Hesperidin)

    Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

    Drug: Daflon

  • Active comparator
    Daflon

    Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

    Drug: Venaflon (Diosmin and Hesperidin)

Interventions

  • DrugDaflon

    Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

  • DrugVenaflon (Diosmin and Hesperidin)

    Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01477281
Lead sponsor
Laboratório Teuto Brasileiro S/A
Responsible party
Sponsor
First posted
Nov 22, 2011
Start date
Feb 2012
Primary completion
Jul 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Nov 22, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion