EXPLORATORY ASSESSMENT OF THE EFFECTS OF CYCLO 3 ® FORT (Ruscus Extract, Hesperidin Methyl Chalcone, Ascorbic Acid) OR MICRONISED PURIFIED FLAVONOID FRACTION ON VASCULAR PARAMETERS AND BIOMARKERS IN WOMEN SUFFERING FROM CHRONIC VENOUS DISEASE (CEAP C2 OR C3), OVER 8 WEEKS

NCT02907320 | Withdrawn Phase 2

• 1 other identifier: DC0982 GE 2 04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial pathology that has an important impact on quality of life and represents a significant public health concern, due to its very high frequency in all European and American (north and south) countries. Venous pathology develops when venous pressure is increased and return of blood is impaired through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue. The aims of this research is to study the effects on microcirculatory activity (activity on very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive technologies will be performed to obtain measurements of microcirculatory parameters in standardized and reproducible conditions for all the participants. In addition, will assess, in blood samples, the inflammatory biomarkers .

Conditions

Venous Disease Classification (CEAP): C2 or C3

Outcome Measures

Primary Outcomes (1)

• Change of Capillary diameter

  Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline.

  From baseline (Day 0) to Day 56

Secondary Outcomes (1)

• Change of venoconstriction activity

  From baseline (Day 0) to Day 56

Study Arms (3)

CYCLO 3 ® FORT and placebo MPFF

EXPERIMENTAL

MPFF = Micronized Purified Flavonoid Fraction

Drug: CYCLO 3 ® FORT; Drug: placebo MPFF

MPFF and placebo CYCLO 3 ® FORT

ACTIVE COMPARATOR

MPFF = Micronized Purified Flavonoid Fraction

Drug: MPFF; Drug: placebo CYCLO 3 ® FORT

placebo

PLACEBO COMPARATOR

MPFF = Micronized Purified Flavonoid Fraction

Drug: placebo CYCLO 3 ® FORT; Drug: placebo MPFF

Interventions

CYCLO 3 ® FORT DRUG

CYCLO 3 ® FORT and placebo MPFF

MPFF DRUG

MPFF and placebo CYCLO 3 ® FORT

placebo CYCLO 3 ® FORT DRUG

MPFF and placebo CYCLO 3 ® FORT; placebo

placebo MPFF DRUG

CYCLO 3 ® FORT and placebo MPFF; placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-menopausal women aged from 18 to 50 years
• Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP
• Regular menstrual cycle
• Use an efficient method of contraception
• Having signed her written informed
• Superficial and or deep venous thrombosis
• Venous insufficiency including history of deep venous thrombosis, post thrombotic syndrome, venous dysplasia, compressive syndrome
• History of venous strapping or phlebotomy/ surgery of the evaluated leg
• Oedema from other etiology
• Paresthesia, cramps of the lower limbs from other origin 2.2 Related to treatment:
• Hypersensitivity, allergy or intolerance to study drugs
• Iron storage disorder
• History of diabetes
• BMI≥ 30
• Grade V and VI on Fitzpatrick classification

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator

Study Officials

• Zahida Issiakhem Belkaid, MD

  Pierre Fabre Medicament

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 20, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share