NCT00862121终止3 期
PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
研究概览
简要总结
The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.
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 (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mesalazine
Experimental
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
干预措施: Pentasa (Drug)
Placebo
Placebo Comparator
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
时间窗: At Week 10, end of treatment
The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to \<150 or a decrease in CDAI score of at least 70.
次要结局
- Relative Change From Baseline to Week 10 in Fecal Calprotectin(At Week 10, end of treatment)
- Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)(Within the 10 week treatment period)
- Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score(Within the 10 week treatment period)
- Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)(Within the 10 week treatment period)
- Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance(At Week 10, end of treatment)
研究者
研究点 (14)
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