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临床试验/NCT00259571
NCT00259571撤回2 期

Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.

Heidelberg University1 个研究点 分布在 1 个国家开始时间: 2005年11月29日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
rate of relapses

研究概览

简要总结

The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.

The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of ulcerative colitis in remission (CAI 3 or less)
  • signed letter of content
  • no steroids or immunosupressants in the last 6 weeks
  • at least 5 relapses in the last 3 years
  • last relapse was 8 months ago or less
  • complete colonoscopy at entry

排除标准

  • pregnancy or breast feeding
  • steroids or immunosuppressants
  • acute episode of UC
  • condition after complete or partial colektomy
  • known intolerance to mesalazin
  • severe medical disease other than colitis

结局指标

主要结局

rate of relapses

relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days

次要结局

  • side effects
  • time to the first relapse
  • endoscopic index
  • life quality
  • amount of relapses per year
  • histolgical score

研究者

申办方类型
Other

研究点 (1)

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