Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)

NCT01110512 | Unknown Phase 3

• 2 other identifiers: FLANEO0210Version 3
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.

Conditions

Venous Insufficiency

Keywords

Improvement of CVI parameters

Outcome Measures

Primary Outcomes (1)

• Improvement of the parameters of CVI, such as edema of lower members.

  There will be 06 planned visits (V0, V1, V2, V3, V4 and V5).

  90 days.

Secondary Outcomes (1)

• Improvement of the parameters of CVI.

  90 days

Study Arms (2)

Flavonid

EXPERIMENTAL

Drug: Flavonid

Daflon

ACTIVE COMPARATOR

Drug: Daflon

Interventions

Flavonid DRUG

Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day.

Flavonid

Daflon DRUG

Diosmin (450 mg) + hesperidin (50 mg) 1 tablet, 2 times per day

Daflon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who agree to the terms described in IC;
• Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
• Subjects with CVI ranked 3 to 5, according to CEAP scale;
• Patients complaining of pain and swelling in the lower limbs secondary to IVC;
• Subjects with good mental health that can respond adequately to the study questionnaires;
• Subjects who agree to make any return visits for evaluation;

You may not qualify if:

• Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
• Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
• Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
• Pregnant or nursing women;
• Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
• Participation in clinical trials in the twelve months preceding the study;
• Patients with serious illnesses and uncontrolled that need multidrug treatment;
• Patients on diuretics of any kind, regardless of pathology (hypertension, renal or liver disease);
• Values of laboratory tests appropriate security; the Hemoglobin \<10 mg / mL the creatinine\> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
• past medical history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alexandre Frederico, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Frederico, Psysician

CONTACT

55 19 3829-3822; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 26, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 27, 2010

Record last verified: 2010-04

Locations

BR (1)