NCT01203397撤回3 期
PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT
EMS1 个研究点 分布在 1 个国家开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy - Symptoms reduction
研究概览
简要总结
Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the treatment of superficial varicose veins
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures, agree to participate, and give written consent.
- •Patients must be able to follow the study medication regimen.
- •Patients with inflammatory process in superficial veins for more than 72 hours.
- •Presence of symmetric lesions to compare one side to the other.
排除标准
- •Pregnancy or risk of pregnancy.
- •Lactation.
- •Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
- •Any alteration at other deep veins.
- •History of atopy or allergic diseases.
- •History of allergy to any component of the formulations.
- •Other conditions considered by the investigator as reasonable for non-eligibility.
研究组 & 干预措施
GROUP 2
Active Comparator
干预措施: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G (Drug)
GROUP 1
Experimental
干预措施: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G (Drug)
结局指标
主要结局
Efficacy - Symptoms reduction
时间窗: Evaluation time: 3 - 7 - 10 and 15 days
The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema.
次要结局
- Efficacy - patient evaluation(15 days)
研究者
研究点 (1)
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