Chronic Venous Disease of Lower LimbsPhase 3EDENNCT01532882
Efficacy and Safety of Diosmin 600mg Versus Placebo on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs
A Phase 3 study testing Diosmin in people with Chronic Venous Disease of Lower Limbs, run by Laboratoire Innotech International at 1 site in France.
Trial summary
Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease of Lower Limbs
- What is being tested?
- Diosmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, man or woman, aged 18 and over,
- Patient presenting a C1s or C2s venous disease grade of the lower limbs
- Patient presenting a painful venous symptomatology in the lower limbs for at least 15 days.
- Patient suffering from venous symptomatology in one leg with a painful symptom intensity higher or equal to 30 mm (VAS= 100mm)
Who cannot join
- Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion,
- Patients who started treatments such as calcium inhibitors, beta-blockers, angiotensin converting enzyme inhibitors and/or vasodilators and/or vasoconstrictors within 28 days prior inclusion (for patients already taking this type of treatments, dosage should not have been changed in the 28 days prior inclusion and should not be planned to change in the course of the study),
- Patient treated by any analgesic within 7 days prior inclusion,
- Patient treated by an anti-inflammatory treatment within 7 days prior inclusion,
- Patient using elastic venous compression
- Patient presenting permanent oedema,
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- Patients presenting venous skin changes,
- Patient whose activity in the 4 following weeks (that is to say during the study) would be different from his/her usual activities (before the study),
- Patient suffering from a pathology generating other pains than venous pains in the lower limbs,
- Patient with a history of lower limbs trauma responsible for sequel pains,
- Patient with a known deep venous reflux,
- Patient with a history of venous thromboses or thrombo-embolic diseases within the last 6 months before inclusion,
- Patient treated with analgesics or anti-inflammatory treatments used as analgesics within 4 weeks prior inclusion
- Patient having a known hypersensitivity to diosmin or one of the excipients
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption ),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy and Safety of Diosmin 600mg on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs: a Multicentric, Randomised, Double-blind, Placebo-controlled Trial in Parallel Groups
Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility.
Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).
The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.
- Conditions
- Chronic Venous Disease of Lower Limbs
- Being tested
- Diosmin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosminDrug
tablet, 600mg, PO, 1 tab per day during 28 days
PlaceboDrug
tablet, PO, 1 per day during 28 days
| Study group | Role | What they receive |
|---|---|---|
| Diosmin | Experimental | Not described Receives: Drug: Diosmin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Visual analog Scale score for assessment of the painful venous symptomatology
Measured: baseline and after 28 days
Secondary outcomes (7)
- Painful symptom intensity (daily VAS score) Area Under the Curve
Measured: 28 days
- Daily VAS score for Response rate
Measured: 28 days
- Daily VAS score for Time to response
Measured: 28 days
- Score of Quality of life questionnaire (SQOR-V)
Measured: Between baseline and 28 days
- Patient's and physician's global satisfaction score
Measured: At 28 days
Adverse Events (numbers and frequency)
Measured: 28 days
- Unusual intakes of analgesic treatments (rate of patients)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous Disease of Lower LimbsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Innotech International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Jérôme GUEX, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532882
- Sponsor's protocol ID
- DIO401-10
- Acronym
- EDEN
- Status last verified
- Apr 2013
- First submitted
- 10 Feb 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.
PubMed 33141449
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of Diosmin 600mg on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs: a Multicentric, Randomised, Double-blind, Placebo-controlled Trial in Parallel Groups
- ClinicalTrials.gov ID
- NCT01532882
- Acronym / sponsor ID
- EDEN / DIO401-10
- Conditions
- Chronic Venous Disease of Lower Limbs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Laboratoire Innotech InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Feb 2012 (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.
Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility.
Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).
The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diosmin | Experimental | Drug: Diosmin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, man or woman, aged 18 and over,
- Patient presenting a C1s or C2s venous disease grade of the lower limbs
- Patient presenting a painful venous symptomatology in the lower limbs for at least 15 days.
- Patient suffering from venous symptomatology in one leg with a painful symptom intensity higher or equal to 30 mm (VAS= 100mm)
Key exclusion criteria (15 listed)
- Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion,
- Patients who started treatments such as calcium inhibitors, beta-blockers, angiotensin converting enzyme inhibitors and/or vasodilators and/or vasoconstrictors within 28 days prior inclusion (for patients already taking this type of treatments, dosage should not have been changed in the 28 days prior inclusion and should not be planned to change in the course of the study),
- Patient treated by any analgesic within 7 days prior inclusion,
- Patient treated by an anti-inflammatory treatment within 7 days prior inclusion,
- Patient using elastic venous compression
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 |
|---|---|---|
| Diosmintablet, 600mg, PO, 1 tab per day during 28 days | Drug | Diosmin |
| Placebotablet, PO, 1 per day during 28 days | Drug | Placebo |
Primary outcome
Change of Visual analog Scale score for assessment of the painful venous symptomatology
Time frame: baseline and after 28 days
7 secondary outcomes
- Painful symptom intensity (daily VAS score) Area Under the Curve
Time frame: 28 days
- Daily VAS score for Response rate
Time frame: 28 days
- Daily VAS score for Time to response
Time frame: 28 days
- Score of Quality of life questionnaire (SQOR-V)
Time frame: Between baseline and 28 days
- Patient's and physician's global satisfaction score
Time frame: At 28 days
Adverse Events (numbers and frequency)
Time frame: 28 days
- Unusual intakes of analgesic treatments (rate of patients)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- Derived from this study: PubMed 33141449Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.
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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.
Jean-Jérôme GUEX, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diosmin in people with Chronic Venous Disease of Lower Limbs, run by Laboratoire Innotech International at 1 site in France.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Visual analog Scale score for assessment of the painful venous symptomatology (time frame: baseline and after 28 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 NCT01532882, which also lists 1 linked publication.
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 29 Apr 2013.