Venous Insufficiency
Conditions
Keywords
Chronic venous insufficiency, Diosmin, Hesperidin
Brief 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. 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.
Interventions
DRUGDiosmin
Diosmin 600mg tablet, once daily
Diosmin 900 mg / Hesperidin 100mg tablet, once daily
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS symptom scores | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Evolution of VAS score at each visit | From pretreatment (month 0) until month 6 of the 6-month treatment period | Evolution of the 100mm VAS symptoms (from 0mm \[absence of venous symptoms\] to 100mm \[maximal intensity of venous symptoms\]) at each visit |
| Efficacy: Patient global satisfaction at each visit | From pretreatment (month 0) until month 6 of the 6-month treatment period | Evaluation of the patient's global satisfaction at each visit on a four level scale of bad, acceptable, good, and very good |
| Oral acceptability | From pretreatment (month 0) until month 6 of the 6-month treatment period | 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 |
| Tolerance: Number of related adverse events during the study | Throughout the 6-month treatment period | Number of related adverse events during the study |
| Efficacy: Investigator's global satisfaction at each visit | From pretreatment (month 0) until month 6 of the 6-month treatment period | Evaluation of the investigator's global satisfaction at each visit on a four level scale of bad, acceptable, good, and very good |
Countries
Brazil
Outcome results
None listed