EUCTR2016-003018-29-DK进行中(未招募)1 期
Apremilast as anti-pruritic treatment in patients with prurigo nodularis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •> 18 years of age
- •PN verified diagnosis by characteristic clinical features
- •Moderate to severe PN
- •Failure of local steroid and light treatment to control disease and symptoms.
- •Be able to speak and understand Danish.
- •Patients must have given their informed consent to the protocol and to the clinical procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
- •Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0
- •Patients who have received any other study medication 4 weeks prior to day 0
- •Patients with other clinically significant disorders
- •Patients with active TB/serious infections
- •Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol
- •Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
- •Patients who have received any live vaccines 6 weeks prior to day 0 or who are planning to receive a live vaccine during the study
研究者
相似试验
Unknown
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撤回
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