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

NCT02927483 | Unknown Phase 3 DMC

• 1 other identifier: OPSUN/0116/FS
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Venous Insufficiency

Keywords

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

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

  180 days

Secondary Outcomes (9)

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

  90 days

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

  30 days

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

  180 days

• 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

  90 days

• 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

  180 days

Study Arms (2)

Endolex Forte®

EXPERIMENTAL

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

Dietary Supplement: Endolex Forte®

A combination of diosmin and hesperidin

ACTIVE COMPARATOR

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.

Dietary Supplement: A combination of diosmin and hesperidin

Interventions

Endolex Forte® DIETARY_SUPPLEMENT

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

Endolex Forte®

A combination of diosmin and hesperidin DIETARY_SUPPLEMENT

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.

A combination of diosmin and hesperidin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• SunWave Pharma: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Related Publications (7)

• 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.

  PMID: 15883226 BACKGROUND

• 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.

  PMID: 10355863 BACKGROUND

• 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.

  PMID: 7707568 BACKGROUND

• 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.

  PMID: 20070899 BACKGROUND

• 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.

  PMID: 21126890 BACKGROUND

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

  PMID: 15387721 BACKGROUND

• 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.

  PMID: 21768702 BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Hesperidin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Officials

• Calin Giurcaneanu, MD

  Spitalul Universitar de Urgenta Elias, Sectia Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dionisio Barattini, MD

CONTACT

+39 335 5437574; barattini@operacro.com

Serban Rosu, MD

CONTACT

+40 722 313224; rosu@operacro.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share