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临床试验/NCT00745199
NCT00745199已完成2 期

Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
62
试验地点
1
主要终点
pruritus

研究概览

简要总结

Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
  • Willing and able to give informed concent

排除标准

  • Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
  • Lactase deficiency

研究组 & 干预措施

1

Experimental

Patients on hemodialysis with pruritus, receiving cromolyn sodium

干预措施: cromolyn sodium (Drug)

2

Experimental

patients on hemodialysis with pruritus, receiving placebo

干预措施: placebo (Drug)

结局指标

主要结局

pruritus

时间窗: 3 months

次要结局

  • serum tryptase level(4 months)

研究者

申办方类型
Other

研究点 (1)

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