NCT01038739终止3 期
Double-blind, Dose-response, Randomised, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
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
- 330
- 试验地点
- 1
- 主要终点
- Proportion of recurrence-free patients at 48 weeks and at 96 weeks:
研究概览
简要总结
The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.
详细描述
The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography
- •Presence of at least one diverticulum of the left colon
- •Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
- •C-reactive protein (CRP) > upper limit of normal (ULN) or leucocytosis at the start of the most recent attack
排除标准
- •Complicated diverticular disease
- •Right-sided diverticulitis
- •Previous colonic surgery
- •Presence of symptomatic organic disease of the gastrointestinal tract
- •Active colorectal cancer or a history of colorectal cancer
- •Hemorrhagic diathesis
- •Active peptic ulcer disease, local intestinal infection
- •Asthma if careful medical monitoring is not ensured
- •Abnormal hepatic function or liver cirrhosis
- •Abnormal renal function
研究组 & 干预措施
C
Placebo Comparator
干预措施: Placebo (Drug)
A
Experimental
干预措施: Mesalazine (Drug)
B
Experimental
干预措施: Mesalazine (Drug)
结局指标
主要结局
Proportion of recurrence-free patients at 48 weeks and at 96 weeks:
时间窗: 48/96 weeks
次要结局
- Stool consistency(48/96 weeks)
- Severity of diarrhea(48/96 weeks)
- Health assessment(48/96 weeks)
- Time to recurrence(48/96 weeks)
- Occurrence of diverticulitis-associated fever(48/96 weeks)
- Number of days with left lower quadrant pain(48/96 weeks)
- Assessment of efficacy by investigator and patient(48/96 weeks)
- Quality of Life (QoL)(48/96 weeks)
研究者
研究点 (1)
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