NCT04882228Unknown4 期
A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group, Non-inferiority Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- CIVIQ-20 questionnaire score change
研究概览
简要总结
This clinical trial is a multi-center, double-blind, randomized, active controlled , parallel design, non-inferiority phase 4 study to evaluate the efficacy and safety of Entelon 150mg in 278 patients with chronic venous disease.
详细描述
This study is to prove that Entelon tab. 150mg is non-inferior in clinical efficacy and safety compared to Venitol tab. for 8 weeks in patients suffering from chronic venous disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years ≤ age ≤ 80 years
- •Those who are diagnosed as CEAP Classification Class 1 ~ Class 3
- •Those who have the Venous Duplex ultrasonography result at least one of the following
- •reflux more than 1 second in Femoral vein or Popliteal vein
- •reflux more that 0.5 second in GSV or SSV or Accessory saphenous vein or perforating vein or calf vein
- •Those who have completed the washout period as following until the baseline, including the screening period
- •Analgesic, corticosteroids, anti-inflammatory drugs: at least 2 weeks
- •Those who provide written consent voluntarily to participate in this clinical trial
排除标准
- •Those who must wear compression stockings
- •Those who have obstruction of the peripheral arteries of the lower extremities
- •Those who have asymptomatic varicose veins
- •Those who have acute deep vein thrombosis
- •Those who have frequent lower extremity pain due to neuropathy
- •Varicose vein surgery patient or prospective person (if surgery was done more than 1 year prior to the time of screening, recruitment is possible)
- •Those who have systemic disease that causes edema or thrombosis
- •Those who have a history of malignant tumors within 5 years prior to the time of screening
- •Those who have severe renal dysfunction at the time of screening (serum creatinine ≥ 2 x upper limit of normal)
- •Those who have severe liver dysfunction at the time of screening (AST or ALT ≥ 3 x upper limit of normal)
- •Those who are required to receive diuretics, analgesics, corticosteroids, anti-inflammatory drugs, or contraindications that may affect the outcome of this clinical trial during the clinical trial period
- •Those who have a history of significant mental illness, alcohol abuse
- •Patients who have an allergy to investigational product or any of its excipients
- •Patients who participated in other clinical trials within 12 weeks prior to the date of screening
- •Pregnant or lactating woman
- •Those who do not agree to use an effective method of contraception
- •Individual considered by the investigator to be ineligible for study participation
研究组 & 干预措施
Venitol tab.
Active Comparator
干预措施: Venitol Tab. (Drug)
Venitol tab.
Active Comparator
干预措施: Placebo of Entelon Tab.150mg (Drug)
Entelon Tab.150mg
Experimental
干预措施: Entelon Tab.150mg (Drug)
Entelon Tab.150mg
Experimental
干预措施: Placebo of Venitol Tab. (Drug)
结局指标
主要结局
CIVIQ-20 questionnaire score change
时间窗: 8week(Visit 4)
Change at week 8 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score
次要结局
- 100mm VAS score change of leg heaviness, leg pain, leg cramps(4week(Visit 3), 8week(Visit 4))
- Venous clinical severity score change(4week(Visit 3), 8week(Visit 4))
- CIVIQ-20 questionnaire score change(4week(Visit 3))
- change in the circumference of the leg due to edema(8week(Visit 4))
- AVVQ questionnaire score change(4week(Visit 3), 8week(Visit 4))
研究者
研究点 (1)
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