Study to Evaluate the Efficacy and Tolerability of Venaflon Use in Reducing the Symptoms Caused by Chronic Venous Insufficiency When Compared With Daflon
This study is not yet open for participant recruitment.
Verified November 2011 by Laboratório Teuto Brasileiro S/A
Sponsor:
Laboratório Teuto Brasileiro S/A
Information provided by (Responsible Party):
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01477281
First received: October 19, 2011
Last updated: November 18, 2011
Last verified: November 2011
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Purpose
The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with Daflon.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Venous Insufficiency Disease |
Drug: Daflon Drug: Venaflon (Diosmin and Hesperidin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Further study details as provided by Laboratório Teuto Brasileiro S/A:
Primary Outcome Measures:
- Improves the symptoms of chronic venous insufficiency with classification CEAP 0-3 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 82 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Venafon (Diosmin and Hesperidin)
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
|
Drug: Daflon
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
|
|
Active Comparator: Daflon
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
|
Drug: Venaflon (Diosmin and Hesperidin)
Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
|
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."
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Laboratório Teuto Brasileiro S/A |
| ClinicalTrials.gov Identifier: | NCT01477281 History of Changes |
| Other Study ID Numbers: | E01-TEU-VEN-08-10 |
| Study First Received: | October 19, 2011 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Laboratório Teuto Brasileiro S/A:
|
chronic venous insufficiency Daflon Venaflon |
Additional relevant MeSH terms:
|
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013