Chronic Venous InsufficiencyPhase 3EVELINENCT02927483
Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency
A Phase 3 study testing Endolex Forte® and A combination of diosmin and hesperidin in people with Chronic Venous Insufficiency, run by SunWave Pharma.
Trial summary
The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Endolex Forte® and A combination of diosmin and hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2017
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.
Read the 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.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Endolex Forte®, A combination of diosmin and hesperidin
- Keywords
- Venous Insufficiency
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endolex Forte®Dietary supplement
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
A combination of diosmin and hesperidinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Endolex Forte® | Experimental | Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. Receives: 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. Receives: Dietary Supplement: A combination of diosmin and hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in limb volume determination at day 180 (water displacement method)
Measured: 180 days
Secondary outcomes (9)
Change from baseline in limb volume determination at day 90 (water displacement method)
Measured: 90 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 30
Measured: 30 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 180
Measured: 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
Measured: 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
Measured: 180 days
Global assessment of efficacy by the investigator at day 180
Measured: 180 days
Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)
Measured: 180 days
Global assessment of tolerability by the investigator at day 180
Measured: 180 days
Adverse events
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SunWave Pharma
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Calin Giurcaneanu, MD, Principal investigator, Spitalul Universitar de Urgenta Elias, Sectia Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927483
- Sponsor's protocol ID
- OPSUN/0116/FS
- Acronym
- EVELINE
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 15883226Olin 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.
PubMed 10355863Porter 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.
PubMed 7707568Rabe 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.
PubMed 20070899Perrin 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.
PubMed 21126890Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available.
PubMed 15387721Sezer 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.
PubMed 21768702
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02927483
- Acronym / sponsor ID
- EVELINE / OPSUN/0116/FS
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Venous Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SunWave PharmaUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endolex Forte® | Experimental | Dietary Supplement: Endolex Forte®Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. |
| A combination of diosmin and hesperidin | Active comparator | Dietary Supplement: A combination of diosmin and hesperidinA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- Known allergy to the product's ingredients
- Pregnancy or breastfeeding
- Patient is involved in any other clinical trial
- Deep vein thrombosis
- Stasis dermatitis
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 |
|---|---|---|
| Endolex Forte®Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. | Dietary supplement | Endolex Forte® |
| A combination of diosmin and hesperidinA 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 |
Primary outcome
Change from baseline in limb volume determination at day 180 (water displacement method)
Time frame: 180 days
9 secondary outcomes
Change from baseline in limb volume determination at day 90 (water displacement method)
Time frame: 90 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 30
Time frame: 30 days
Change from pre-treatment (baseline) in the calf circumference on treatment day 180
Time frame: 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
Time frame: 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
Time frame: 180 days
Global assessment of efficacy by the investigator at day 180
Time frame: 180 days
Questionnaire on improvement in symptoms at day 180 (CIVIQ-20)
Time frame: 180 days
Global assessment of tolerability by the investigator at day 180
Time frame: 180 days
Adverse events
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 15883226Eberhardt 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.
- Background: PubMed 10355863Olin 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.
- Background: PubMed 7707568Porter 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.
- Background: PubMed 20070899Rabe 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.
- Background: PubMed 21126890Perrin 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.
- Background: PubMed 15387721Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. No abstract available.
- Background: PubMed 21768702Sezer 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.
- Individual participant dataSharing planned: Yes
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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.
Calin Giurcaneanu, MD principal investigator
Spitalul Universitar de Urgenta Elias, Sectia Dermatologie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endolex Forte® and A combination of diosmin and hesperidin in people with Chronic Venous Insufficiency, run by SunWave Pharma.
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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dionisio Barattini, MD (+39 335 5437574, barattini@operacro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in limb volume determination at day 180 (water displacement method) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927483, which also lists 7 linked publications.
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 28 Oct 2016.