Venous Disease Classification (CEAP): C2 or C3Phase 2NCT02907320
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
A Phase 2 study testing CYCLO 3 ® FORT and MPFF in people with Venous Disease Classification (CEAP): C2 or C3, run by Pierre Fabre Medicament.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Venous Disease Classification (CEAP): C2 or C3
- What is being tested?
- CYCLO 3 ® FORT and MPFF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
None listed.
About this study
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 .
- Being tested
- CYCLO 3 ® FORT, MPFF, placebo CYCLO 3 ® FORT, placebo MPFF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYCLO 3 ® FORTDrug
MPFFDrug
placebo CYCLO 3 ® FORTDrug
placebo MPFFDrug
| Study group | Role | What they receive |
|---|---|---|
| CYCLO 3 ® FORT and placebo MPFF | Experimental | MPFF = Micronized Purified Flavonoid Fraction Receives: Drug: CYCLO 3 ® FORT; Drug: placebo MPFF |
| MPFF and placebo CYCLO 3 ® FORT | Active comparator | MPFF = Micronized Purified Flavonoid Fraction Receives: Drug: MPFF; Drug: placebo CYCLO 3 ® FORT |
| placebo | Placebo comparator | MPFF = Micronized Purified Flavonoid Fraction Receives: Drug: placebo CYCLO 3 ® FORT; Drug: placebo MPFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Capillary diameter
Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline.
Measured: From baseline (Day 0) to Day 56
Secondary outcomes (1)
Change of venoconstriction activity
Measure by Duplex-scan of vein diameter in millimeter on the worst leg (CEAP classification C2 or C3) at Baseline.
Measured: From baseline (Day 0) to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startDec 2016 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Disease Classification (CEAP): C2 or C3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Responsible party
- Sponsor
- Investigators
- Zahida Issiakhem Belkaid, MD, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907320
- Sponsor's protocol ID
- DC0982 GE 2 04
- Status last verified
- Feb 2017
- First submitted
- 8 Sep 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02907320
- Acronym / sponsor ID
- DC0982 GE 2 04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Study start
- Dec 2016 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYCLO 3 ® FORT and placebo MPFF | Experimental | Drug: CYCLO 3 ® FORT, Drug: placebo MPFFMPFF = Micronized Purified Flavonoid Fraction |
| MPFF and placebo CYCLO 3 ® FORT | Active comparator | Drug: MPFF, Drug: placebo CYCLO 3 ® FORTMPFF = Micronized Purified Flavonoid Fraction |
| placebo | Placebo comparator | Drug: placebo CYCLO 3 ® FORT, Drug: placebo MPFFMPFF = Micronized Purified Flavonoid Fraction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Inclusion criteria
- Non-inclusion criteria 2.1 Related to pathology:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Change of Capillary diameter
Time frame: From baseline (Day 0) to Day 56
Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline.
1 secondary outcome
Change of venoconstriction activity
Time frame: From baseline (Day 0) to Day 56
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahida Issiakhem Belkaid, MD study director
Pierre Fabre Medicament
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYCLO 3 ® FORT and MPFF in people with Venous Disease Classification (CEAP): C2 or C3, run by Pierre Fabre Medicament.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Capillary diameter (time frame: From baseline (Day 0) to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.