NCT00835822已完成4 期
Multicenter, Prospective, Randomized, Double-Blind Study to Assess the Therapeutic Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 216
- 主要终点
- Reduction of the score of the CVI symptoms, based on symptoms as leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness)
研究概览
简要总结
The purpose of this study is to assess the therapeutic efficacy and safety of Venocur Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated between CEAP 2 and 4, in comparison to a Placebo group.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC)
- •Patients of both sexes, aged above 18 years and below 65 years
- •Presence of uni- or bilateral varicose veins with CVI, in both sexes
- •The patient's CVI is rated between functional classes CEAP 2 and 4
- •Present at least one symptom of CVI prior to the study - leg pains, cramps, fatigue, heavy legs sensation.
排除标准
- •If female, the patient has circulatory disorders exclusively during the pre-menstrual period
- •If the patient is pregnant or breastfeeding
- •The patient has received anticoagulants less than 15 days before study start
- •The patient has used steroids or anti-inflammatory drugs less than 8 days before study start
- •The patient has received radio or chemotherapy less than 7 days before study start
- •The patient has used diuretics, phlebotrophic and venoactive drugs over the past 8 days before enrollment in the study
- •The patient has used compression stockings less than 8 days before study start
- •Trauma or surgical treatment over the past 30 days before study start
- •Prior surgical treatment related to CVI (past 12 months for surgery and past 6 months for sclerotherapy)
- •Immobilization of lower limbs over the past 6 months
- •Known allergy to the product's ingredients
- •Presence of chronic inflammatory diseases (rheumatoid arthritis, for instance), severe chronic infectious diseases (AIDS, tuberculosis, hanseniasis, etc.)
- •The patient has suffered from phlebitis or deep venous thrombosis in the past 6 months before the study
- •Fibrous lymphedema, primary or secondary lymphedema and lipoedema;
- •Concomitant erysipelas
- •Active fungal infections of the lower limbs
- •Peripheral arteries disease, cerebrovascular or coronary disease
- •Severe systemic conditions (heart failure, liver, pulmonary or kidney failure, active neoplastic disease, severe arterial hypertension, uncontrolled diabetes, among others), over the past 6 months before study start
- •Hematocrit: < 32.0 mL RBC/dL for women and < 36.0 mL RBC/dL for men
- •Hemoglobin: < 11.0 mL g/dL for women and < 12.0 mL g/dL for men;
- •Total protein and fractions: Total protein < 6.4 g/dL, Albumin < 4.0 g/dL, Globulin < 1g/dL and Albumin/Globulin < 0.9%
- •Serum creatinine: > 1.0 mg/dL for women and > 1.2 mg/dL for men or if patient in dialysis
- •Aminotranferases (SGOT/AST and/or SGPT/ALT) more than twice the upper normal limit
- •Participation in study with similar objectives over the past 6 months.
研究组 & 干预措施
A
Experimental
Arm treated with Investigational product.
干预措施: Venocur Triplex® (Drug)
B
Placebo Comparator
Arm treated with placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Reduction of the score of the CVI symptoms, based on symptoms as leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness)
时间窗: 60 days
Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness);
Safety Assessment through the adverse events reports
次要结局
- Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group
- Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ(60 days)
- The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale.(60 days)
研究者
相似试验
招募中
2 期
Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAMLSecondary Acute Myeloid LeukemiaNCT05513131The First Affiliated Hospital with Nanjing Medical University30
招募中
3 期
Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AMLAcute Myeloid LeukemiaNCT05264883The First Affiliated Hospital with Nanjing Medical University170
尚未招募
4 期
Vunakizumab in Adults with SpondyloarthritisSpondyloarthritis (SpA)NCT06770088Sun Yat-sen University880
已完成
不适用
A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian FederationChronic Lymphocytic Leukemia (CLL)CancerNCT03873857AbbVie71
已完成
不适用
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow ObstructionChronic Venous DisorderVenous Outflow ObstructionSymptomatic Venous Outflow Obstruction of Iliofemoral VeinNCT02112877Boston Scientific Corporation200