Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency
- Registration Number
- NCT03471910
- Lead Sponsor
- Fundação Educacional Serra dos Órgãos
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diosmin + Hesperidin Diosmin / Hesperidin Diosmin 900mg + Hesperidin 100mg, one tablet once daily Diosmin Diosmin Diosmin 600mg, one tablet once daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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"
Tolerance: Number of related adverse events during the study Throughout the 6-month treatment period Number of related adverse events during the study
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
Trial Locations
- Locations (1)
Centro Universitário Serra dos Órgãos - UNIFESO
🇧🇷Teresópolis, RJ, Brazil