NCT00261079已完成4 期
The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 435
- 试验地点
- 2
- 主要终点
- The change of physician's assessment on pruritic score before and after 7-day treatment.
研究概览
简要总结
Primary objective:
- To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease
Secondary objective:
- To evaluate patient's satisfaction of Allegra 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
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- •Main criteria are listed hereafter:
- •Inclusion Criteria:
- •All patients diagnosed with atopic dermatitis, contact dermatitis
排除标准
- •Other skin disease except atopic dermatitis, contact dermatitis.
- •Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
- •Pruritus localized only head and face
- •Subjects with severe hepatic, renal, heart dysfunction.
- •Subjects with history of alcohol and drug abuse.
- •Pregnant and lactating women.
结局指标
主要结局
The change of physician's assessment on pruritic score before and after 7-day treatment.
次要结局
- Patient visual analogue scale change and Overall satisfaction.
研究者
研究点 (2)
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