A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
研究概览
简要总结
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
- •Ability to comprehend and sign an informed consent document and complete study questionnaires in English
- •Ability to record symptoms in accordance with the protocol
- •Symptomatic varicose veins
- •Visible varicose veins
排除标准
- •Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
- •Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
- •Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
- •Deep vein reflux unless clinically insignificant in comparison to superficial reflux
- •Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
- •Reduced mobility
- •Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
- •Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
- •Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
- •Current alcohol or drug abuse
- •Pregnant or lactating women
- •Women of childbearing potential not using effective contraception
- •History of DVT, pulmonary embolism or stroke
研究组 & 干预措施
Polidocanol injectable foam 0.125%
Polidocanol injectable foam 0.125%
干预措施: Polidocanol injectable foam (PEM) (Drug)
Polidocanol injectable foam 0.5%
Polidocanol injectable foam 0.5%
干预措施: Polidocanol injectable foam (PEM) (Drug)
Polidocanol injectable foam 1.0%
Polidocanol injectable foam 1.0%
干预措施: Polidocanol injectable foam (PEM) (Drug)
Polidocanol injectable foam 2.0%
Polidocanol injectable foam 2.0%
干预措施: Polidocanol injectable foam (PEM) (Drug)
Vehicle
Injection of vehicle comparator
干预措施: Placebo Vehicle (Drug)
结局指标
主要结局
Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
时间窗: Week 8
The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated
次要结局
- Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance(8 weeks post treatment)
- Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)(8 weeks)