Venous InsufficiencyPhase 4NCT03471910
Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency
A Phase 4 study testing Diosmin and Diosmin / Hesperidin in people with Venous Insufficiency, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
Trial summary
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Diosmin and Diosmin / 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
- 1 siteBrazil
- Study dates
- 20 Jun 2017to 30 Apr 2018
- Phase
- Phase 4
- 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
- Patients of both genders >18 years old
- Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
- Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
- Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
- Subject has read, understood, dated and signed the informed consent form
Who cannot join
- Treatment by compression stocking within the 2 months before inclusion
- Treatment by venotonics within the 2 months before inclusion
- Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
- Known allergy or hypersensitivity to any component of the study drug
- Known clinically significant laboratory alterations
- CEAP levels 4, 5 \& 6
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- Patient with venous disease requiring surgery / chemical endovenous sclerotherapy
- Patient suffering from a painful pathology other than the venous pain in the lower limbs
- Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion
- Patient with alteration of general condition incompatible with his / her participation in the trial
- Patient wishing to be pregnant in the 6 following months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, 25964004
About this study
Official title: Clinical Non-inferiority Study Between Diosmin 600 mg Tablets and Diosmin 900 mg + Hesperidin 100 mg Tablets in Symptomatic Chronic Venous Insufficiency After 6 Months of Treatment: Single-blind, Randomized, Parallel Group Study
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.
Read the detailed description
The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.
The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:
- The oral acceptability,
- The tolerability,
- The global patient's satisfaction,
- The global physician's satisfaction.
Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:
- Efficacy on venous symptoms : The VAS of 100 mm is rated by the patient from "0" = Absence of venous symptoms up to "100" = Maximal intensity of the venous symptoms. The VAS is completed by the patient at the investigator's office. This VAS globally assesses the venous symptomatology of the most symptomatic leg : Heavy legs, Painful legs, Tired legs, Sensation of swelling and/or tension in the legs).
- Acceptability : Easiness to swallow assessed by a VAS of 100 mm rated by the patient from "0" = Very easy to swallow, up to "10" = Very difficult to swallow
- Patient's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
- Investigator's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
- Tolerability (related adverse events)
- Compliance : Accountability of treatments returned by the patient
The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.
- Conditions
- Venous Insufficiency
- Being tested
- Diosmin, Diosmin / Hesperidin
- Keywords
- Chronic venous insufficiency, Diosmin, Hesperidin
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosminDrug
Diosmin 600mg tablet, once daily
Diosmin / HesperidinDrug
Diosmin 900 mg / Hesperidin 100mg tablet, once daily
| Study group | Role | What they receive |
|---|---|---|
| Diosmin | Experimental | Diosmin 600mg, one tablet once daily Receives: Drug: Diosmin |
| Diosmin + Hesperidin | Active comparator | Diosmin 900mg + Hesperidin 100mg, one tablet once daily Receives: Drug: Diosmin / Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS symptom scores
Change between the 100mm visual analog scale (VAS) symptoms (from 0mm [absence of venous symptoms] to 100mm [maximal intensity of venous symptoms] scores at month 0 (pretreatment) and month 6 / end of study visit (early withdrawal).
Measured: From pretreatment (month 0) until month 6 of the 6-month treatment period
Secondary outcomes (5)
Efficacy: Evolution of VAS score at each visit
Evolution of the 100mm VAS symptoms (from 0mm [absence of venous symptoms] to 100mm [maximal intensity of venous symptoms]) at each visit
Measured: From pretreatment (month 0) until month 6 of the 6-month treatment period
Efficacy: Patient global satisfaction at each visit
Evaluation of the patient's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"
Measured: From pretreatment (month 0) until month 6 of the 6-month treatment period
Oral acceptability
Evaluation of the oral acceptability on a 100mm VAS (from 0mm - very easy to swallow to 100mm - very difficult to swallow) of the treatment at each visit
Measured: From pretreatment (month 0) until month 6 of the 6-month treatment period
Tolerance: Number of related adverse events during the study
Number of related adverse events during the study
Measured: Throughout the 6-month treatment period
Efficacy: Investigator's global satisfaction at each visit
Evaluation of the investigator's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"
Measured: From pretreatment (month 0) until month 6 of the 6-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start20 Jun 2017
- Primary completion20 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
- Investigators
- Marcio Steinbruch, MD, Principal investigator, Hospital Albert EinsteinRenato Kaufman, MD, Principal investigator, Universidade Estadual do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471910
- Sponsor's protocol ID
- DIVC-01-12-17
- Status last verified
- Jun 2018
- First submitted
- 27 Feb 2018
- Last updated
- 20 Jun 2018
- 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 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Non-inferiority Study Between Diosmin 600 mg Tablets and Diosmin 900 mg + Hesperidin 100 mg Tablets in Symptomatic Chronic Venous Insufficiency After 6 Months of Treatment: Single-blind, Randomized, Parallel Group Study
- ClinicalTrials.gov ID
- NCT03471910
- Acronym / sponsor ID
- DIVC-01-12-17
- Conditions
- Venous Insufficiency
- Keywords
- Chronic venous insufficiency, Diosmin, Hesperidin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- 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.
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.
Detailed description
The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.
The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:
- The oral acceptability,
- The tolerability,
- The global patient's satisfaction,
- The global physician's satisfaction.
Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:
- Efficacy on venous symptoms : The VAS of 100 mm is rated by the patient from "0" = Absence of venous symptoms up to "100" = Maximal intensity of the venous symptoms. The VAS is completed by the patient at the investigator's office. This VAS globally assesses the venous symptomatology of the most symptomatic leg : Heavy legs, Painful legs, Tired legs, Sensation of swelling and/or tension in the legs).
- Acceptability : Easiness to swallow assessed by a VAS of 100 mm rated by the patient from "0" = Very easy to swallow, up to "10" = Very difficult to swallow
- Patient's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
- Investigator's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
- Tolerability (related adverse events)
- Compliance : Accountability of treatments returned by the patient
The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diosmin | Experimental | Drug: DiosminDiosmin 600mg, one tablet once daily |
| Diosmin + Hesperidin | Active comparator | Drug: Diosmin / HesperidinDiosmin 900mg + Hesperidin 100mg, one tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders >18 years old
- Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
- Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
- Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
- Subject has read, understood, dated and signed the informed consent form
Key exclusion criteria (11 listed)
- Treatment by compression stocking within the 2 months before inclusion
- Treatment by venotonics within the 2 months before inclusion
- Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
- Known allergy or hypersensitivity to any component of the study drug
- Known clinically significant laboratory alterations
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 |
|---|---|---|
| DiosminDiosmin 600mg tablet, once daily | Drug | Diosmin |
| Diosmin / HesperidinDiosmin 900 mg / Hesperidin 100mg tablet, once daily | Drug | Diosmin + Hesperidin |
Primary outcome
Change in VAS symptom scores
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Change between the 100mm visual analog scale (VAS) symptoms (from 0mm [absence of venous symptoms] to 100mm [maximal intensity of venous symptoms] scores at month 0 (pretreatment) and month 6 / end of study visit (early withdrawal).
5 secondary outcomes
Efficacy: Evolution of VAS score at each visit
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Efficacy: Patient global satisfaction at each visit
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Oral acceptability
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
Tolerance: Number of related adverse events during the study
Time frame: Throughout the 6-month treatment period
Efficacy: Investigator's global satisfaction at each visit
Time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period
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 20 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Marcio Steinbruch, MD principal investigator
Hospital Albert Einstein
Renato Kaufman, MD principal investigator
Universidade Estadual do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diosmin and Diosmin / Hesperidin in people with Venous Insufficiency, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
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 5 inclusion and 11 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 20 Jun 2018. 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 Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in VAS symptom scores (time frame: From pretreatment (month 0) until month 6 of the 6-month treatment period). 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 Jun 2018.