CTIS2023-503957-36-00进行中（未招募）1 期
A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects with Notalgia Paresthetica - CR845-310601
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 577
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •To be eligible for inclusion into the study, a patient must meet the following criteria: Has moderate to severe pruritus;, Has at least a 6-month history of chronic pruritus due to NP;, Presence of hyper- or hypopigmented macules, hyperkeratosis, lichenification, and/or excoriation in the middle to upper back in the vicinity of the scapula;, Has NP-related pruritus that is considered appropriate for systemic therapy;, Female subject is not pregnant or nursing during any period of the study.
排除标准
- •A patient will be excluded from the study if any of the following criteria are met: Subject has pruritus attributed to a cause other than NP;, Has a history of skin disease or presence of skin condition other than those related to NP that, in the opinion of the Investigator, would interfere with the study assessments;, Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
研究者
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