NCT00152620终止不适用
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pediatric Crohn's Disease Activity Index (PCDAI)
研究概览
简要总结
The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental informed consent
- •Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of >
- •Infectious causes (viruses, bacteria, parasites) have been ruled out.
排除标准
- •Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens.
- •Subjects with enterostomy or colostomy
- •Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
结局指标
主要结局
Pediatric Crohn's Disease Activity Index (PCDAI)
Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
次要结局
- Partial Harvey Bradshaw score (pHB)
研究者
研究点 (2)
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