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临床试验/NCT00040521
NCT00040521已完成2 期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease

Wyeth is now a wholly owned subsidiary of Pfizer2 个研究点 分布在 1 个国家开始时间: 2002年4月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
试验地点
2

研究概览

简要总结

The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from 220-400).

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
  • Men and women age 16 years and over.
  • Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)

排除标准

  • Use of the following medications within the specified time period prior to randomization:
  • Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid)
  • Codeine-containing compounds
  • Corticosteroid enemas

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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