EUCTR2011-003743-22-IT进行中（未招募）1 期
A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 123
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
- 性别
- All
入选标准
- •1.All male and female subjects must be aged 5 to 17, inclusive, and must
- •not have reached their 18th birthday by the estimated final office visit
- •2.Subject must be diagnosed with active Crohn's disease of the ileum
- •and/or ascending colon confirmed by endoscopic and/or radiographic
- •evidence, and/or evidence of mucosal erosions and/or histology within
- •the last year
- •3.Subjects with mild to moderate Crohn's disease
- •4.All subjects must have a stool analysis negative for Clostridium
- •difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella,
- •Shigella, within the 30 days prior to visit 1
- •5.Alls subjects must have had laboratory assessments within 7 days
- •prior to visit 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who have had any previous intestinal resection proximal to
- •and including the ascending colon
- •2.Subjects with evidence of severe active Crohn's Disease and/or,
- •structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
- •3.Subjects who do not have a negative stool analysis, within the 30 days
- •prior to Visit 1
- •4.Subjects who have been screened/or enrolled in this study previously
- •within the last 6 months
研究者
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