NCT01627262已完成2 期
Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
研究概览
简要总结
The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diverticular disease with acute pain without serious complications
- •Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion
排除标准
- •Chronic inflammatory bowel disease
- •Fever or other signs of serious complications.
研究组 & 干预措施
Mesalamine
Experimental
干预措施: Mesalamine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
时间窗: 4 weeks
The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4
次要结局
未报告次要终点
研究者
研究点 (1)
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