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Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency (EVELINE)

Primary Purpose

Chronic Venous Insufficiency

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Endolex Forte®

A combination of diosmin and hesperidin

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring Venous Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients, male or females aged 18 to 75 years old
BMI≤40
Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
Willing and able to give written informed consent prior to participation in the trial
Patients expected to be compliant with the study treatment

Exclusion Criteria:

Known allergy to the product's ingredients
Pregnancy or breastfeeding
Patient is involved in any other clinical trial
Deep vein thrombosis
Stasis dermatitis
The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
Open ulcers or lower extremity amputation
Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
Patient presenting permanent oedema,
Patient with a history of lower limbs trauma responsible for sequel pains
NYHA III and IV Heart Failure
Renal Failure
Untreated or uncontrolled Arterial Hypertension
Hepatic Failure
History of a known liver disease such as hepatitis A, hepatitis B, or C.
Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years
Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol.
Immobility.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endolex Forte®

A combination of diosmin and hesperidin

Arm Description

Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.

A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day.

Outcomes

Primary Outcome Measures

Change from baseline in limb volume determination at day 180 (water displacement method)

Secondary Outcome Measures

Change from baseline in limb volume determination at day 90 (water displacement method)

Change from pre-treatment (baseline) in the calf circumference on treatment day 30

Change from pre-treatment (baseline) in the calf circumference on treatment day 180

Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90

Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180

Global assessment of efficacy by the investigator at day 180

Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)

Global assessment of tolerability by the investigator at day 180

Adverse events

Full Information

NCT ID

NCT02927483

First Posted

October 6, 2016

Last Updated

October 27, 2016

Sponsor

SunWave Pharma

Collaborators

Opera CRO, a TIGERMED Group Company

1. Study Identification

Unique Protocol Identification Number

NCT02927483

Brief Title

Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency

Acronym

EVELINE

Official Title

A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SunWave Pharma

Collaborators

Opera CRO, a TIGERMED Group Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.

Detailed Description

A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Venous Insufficiency

Keywords

Venous Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endolex Forte®

Arm Type

Experimental

Arm Description

Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.

Arm Title

A combination of diosmin and hesperidin

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Endolex Forte®

Intervention Description

Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

A combination of diosmin and hesperidin

Intervention Description

Primary Outcome Measure Information:

Title

Change from baseline in limb volume determination at day 180 (water displacement method)

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Change from baseline in limb volume determination at day 90 (water displacement method)

Time Frame

90 days

Title

Change from pre-treatment (baseline) in the calf circumference on treatment day 30

Time Frame

30 days

Title

Change from pre-treatment (baseline) in the calf circumference on treatment day 180

Time Frame

180 days

Title

Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90

Time Frame

90 days

Title

Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180

Time Frame

180 days

Title

Global assessment of efficacy by the investigator at day 180

Time Frame

180 days

Title

Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)

Time Frame

180 days

Title

Global assessment of tolerability by the investigator at day 180

Time Frame

180 days

Title

Adverse events

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients, male or females aged 18 to 75 years old BMI≤40 Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4 Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days. Willing and able to give written informed consent prior to participation in the trial Patients expected to be compliant with the study treatment Exclusion Criteria: Known allergy to the product's ingredients Pregnancy or breastfeeding Patient is involved in any other clinical trial Deep vein thrombosis Stasis dermatitis The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form) Open ulcers or lower extremity amputation Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion Patient presenting permanent oedema, Patient with a history of lower limbs trauma responsible for sequel pains NYHA III and IV Heart Failure Renal Failure Untreated or uncontrolled Arterial Hypertension Hepatic Failure History of a known liver disease such as hepatitis A, hepatitis B, or C. Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol. Immobility.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dionisio Barattini, MD

Phone

+39 335 5437574

barattini@operacro.com

First Name & Middle Initial & Last Name or Official Title & Degree

Serban Rosu, MD

Phone

+40 722 313224

rosu@operacro.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Calin Giurcaneanu, MD

Organizational Affiliation

Spitalul Universitar de Urgenta Elias, Sectia Dermatologie

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

15883226

Citation

Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.

Results Reference

background

PubMed Identifier

10355863

Citation

Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. doi: 10.1177/1358836X9900400101.

Results Reference

background

PubMed Identifier

7707568

Citation

Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995 Apr;21(4):635-45. doi: 10.1016/s0741-5214(95)70195-8.

Results Reference

background

PubMed Identifier

20070899

Citation

Rabe E, Stucker M, Ottillinger B. Water displacement leg volumetry in clinical studies--a discussion of error sources. BMC Med Res Methodol. 2010 Jan 13;10:5. doi: 10.1186/1471-2288-10-5.

Results Reference

background

PubMed Identifier

21126890

Citation

Perrin M, Ramelet AA. Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):117-25. doi: 10.1016/j.ejvs.2010.09.025. Epub 2010 Dec 3.

Results Reference

background

PubMed Identifier

15387721

Citation

Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available.

Results Reference

background

PubMed Identifier

21768702

Citation

Sezer A, Usta U, Kocak Z, Yagci MA. The effect of a flavonoid fractions diosmin + hesperidin on radiation-induced acute proctitis in a rat model. J Cancer Res Ther. 2011 Apr-Jun;7(2):152-6. doi: 10.4103/0973-1482.82927.

Results Reference

background

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Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency

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