Clinical trial NCT02927483: Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Venous Insufficiency
Keywords: Venous Insufficiency
Lead sponsor: SunWave Pharma
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-10-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in limb volume determination at day 180 (water displacement method)
timeFrame: 180 days
Secondary outcomes:
measure: Change from baseline in limb volume determination at day 90 (water displacement method)
timeFrame: 90 days
measure: Change from pre-treatment (baseline) in the calf circumference on treatment day 30
timeFrame: 30 days
measure: Change from pre-treatment (baseline) in the calf circumference on treatment day 180
timeFrame: 180 days
measure: 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
timeFrame: 90 days
measure: 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
timeFrame: 180 days
measure: Global assessment of efficacy by the investigator at day 180
timeFrame: 180 days
measure: Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)
timeFrame: 180 days
measure: Global assessment of tolerability by the investigator at day 180
timeFrame: 180 days
measure: Adverse events
timeFrame: 180 days
Other outcomes:
Locations:
Study officials:
affiliation: Spitalul Universitar de Urgenta Elias, Sectia Dermatologie
name: Calin Giurcaneanu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available.
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.