NCT00245947已完成1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 22 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Inflammatory serum markers
研究概览
简要总结
Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
- •Eligible subjects must have adequate hematologic, renal, and hepatic function.
- •Other inclusions apply
排除标准
- •Use of the following medications within the specified time period before randomization is prohibited:
- •Within 48 hours before randomization
- •Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
- •Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).
- •Other exclusions applies
结局指标
主要结局
Inflammatory serum markers
Pharmacogenomics
Safety
次要结局
- Crohn's Disease Activity Index (CDAI) scores.
- Cell surface markers
- Fecal markers
研究者
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