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临床试验/EUCTR2016-003018-29-DK
EUCTR2016-003018-29-DK进行中(未招募)1 期

Apremilast as anti-pruritic treatment in patients with prurigo nodularis

Herlev and Gentofte Hospital0 个研究点目标入组 20 人开始时间: 2017年2月3日最近更新:
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

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