EXPLORATORY ASSESSMENT OF THE EFFECTS OF CYCLO 3 ® FORT (... | NCT02907320

Studies
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

Sponsor

Pierre Fabre Medicament

Status

Withdrawn

Last Update Posted

Feb 20, 2017Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Venous Disease Classification (CEAP): C2 or C3

Interventions

CYCLO 3 ® FORT
MPFF
placebo CYCLO 3 ® FORT
placebo MPFF

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Estimated

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 15, 2016

First Posted Date

Sep 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2017

Last Update Posted Date

Feb 20, 2017Actual

Name	Class
Eurotrials Brasil Consultores Cientificos Ltda	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CYCLO 3 ® FORT	Drug		CYCLO 3 ® FORT and placebo MPFF
MPFF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change of venoconstriction activity	Measure by Duplex-scan of vein diameter in millimeter on the worst leg (CEAP classification C2 or C3) at Baseline.	From baseline (Day 0) to Day 56

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria
- 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
Non-inclusion criteria 2.1 Related to pathology:
- 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
- Sclerosing injection within 6 month before inclusion
- 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
- Intake of venotonic treatment (oral or topic) ,triptan ,diuretics ,calcium blockers, beta blockers, ACE inhibitors, angiotensine II inhibitors, vasodilatators and/or vasoconstrictors within 1 month before inclusion
- Intake of NSAID,corticosteroids,ergotamine, dihydroergotamine or any ergot alkaloids,vitamin C nutraceutical or phytotherapy products with potential venotonic effect within 2 weeks before inclusion 2.3 Related to the population:
- History of diabetes
- BMI≥ 30
- Grade V and VI on Fitzpatrick classification

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Zahida Issiakhem Belkaid, MD	Pierre Fabre Medicament	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided