NCT00980629已完成2 期
A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 8
- 主要终点
- Pruritus score
研究概览
简要总结
This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
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
- •Male or female patients (aged 18-65 years) with a diagnosis of AD.
- •Female patients of child bearing potential must be using a medically acceptable form of contraception.
- •Patients who are able and willing to give signed informed consent.
- •Patients who have pruritus exceed the reference range.
排除标准
- •Patients who have a history of allergy to hydrocortisone.
- •Patients who have a history of relevant drug hypersensitivity.
- •Patients who have a history of contact dermatitis induced by a topical steroid.
- •Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
- •Patients who have a history or presence of any cancer.
- •Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
- •Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- •Patients who have pruritus associated with conditions other than AD.
- •Patients who have pruritus only on the face and head.
- •Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
- •Patients who have used M5161(active ingredient of M516102).
- •Patients who cannot communicate reliably with the investigator.
- •Patients who are pregnant or lactating.
- •Patients who have used any IMP and/or participated in any clinical trial within 3 months.
结局指标
主要结局
Pruritus score
次要结局
未报告次要终点
研究者
研究点 (8)
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