NCT01453946已完成3 期
A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
详细描述
A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •All subjects must weight >= 15 kg at the time of enrollment.
- •Subjects must have been diagnosed and treated for 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 and have a PCDAI <= 10
排除标准
- •Subjects who have had any previous intestinal resection proximal to and including the ascending colon.
- •Subjects with evidence of active Crohn's disease (PCDAI > 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.
- •Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.
研究组 & 干预措施
Entocort
Other
Study Medication
干预措施: Entocort (Drug)
结局指标
主要结局
Adverse Event
时间窗: 16 weeks
Any kind of adverse event
次要结局
- PCDAI(12 weeks)
- IMPACT 3(12 weeks)
研究者
研究点 (1)
Loading locations...
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