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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in VAS symptom scores
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diosmin
Diosmin 600mg, one tablet once daily
干预措施: Diosmin (Drug)
Diosmin + Hesperidin
Diosmin 900mg + Hesperidin 100mg, one tablet once daily
干预措施: Diosmin / Hesperidin (Drug)
结局指标
主要结局
Change in VAS symptom scores
时间窗: 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).
次要结局
- Efficacy: Patient global satisfaction at each visit(From pretreatment (month 0) until month 6 of the 6-month treatment period)
- Oral acceptability(From pretreatment (month 0) until month 6 of the 6-month treatment period)
- Efficacy: Investigator's global satisfaction at each visit(From pretreatment (month 0) until month 6 of the 6-month treatment period)
- Tolerance: Number of related adverse events during the study(Throughout the 6-month treatment period)
- Efficacy: Evolution of VAS score at each visit(From pretreatment (month 0) until month 6 of the 6-month treatment period)
研究者
Carlos Pereira Nunes
Professor of Internal Medicine
Fundação Educacional Serra dos Órgãos