a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
研究概览
简要总结
a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.
- Endpoint: VAS Score Change, Investigator's assessment of overall treatment
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender, 19 years ≤ age
- •Patients with pruritus due to the following diseases
- •① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema
- •② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis
- •③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)
- •④ systemic skin pruritus, focal skin pruritus
- •In visit 2, during the run-in period previous week the VAS score of day and night time were 2 or more average points per day (maximum 4 points)
- •Those who can ability to record subject diary
- •Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
排除标准
- •Patients with pruritus due other medical causes (liver disease, heart failure, etc.)
- •Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease
- •Patients with systemic infection symptoms at the time of clinical trials
- •Asthmatic patients requiring steroid treatment
- •Patients with Spastic diseases such as epilepsy
研究组 & 干预措施
Experimental
Experimental: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (1Tab)+Talion Tab (Placebo)(1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab)
干预措施: HL151 (Drug)
Active comparator
Comparator: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)
干预措施: Talion Tab (Drug)
结局指标
主要结局
Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
时间窗: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
次要结局
- Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration(Visit 2 (0 week), Visit 3 (1 week))
- Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline(Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks))
- Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)(Visit 4 (2 weeks))
- Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline(Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)