NCT00742872终止3 期
A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome
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
- 41
- 试验地点
- 1
- 主要终点
- Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
研究概览
简要总结
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rome III Criteria for IBS:
- •Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:
- •Relieved by defecation
- •Onset associated with a change in stool frequency
- •Onset associated with a change in stool form or appearance
- •In addition, patients have to experience at least two of the following symptoms for at least 25% of the time [11]:
- •Altered stool frequency (< 3 bowel movements per week)
- •Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1])
- •Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
- •Passage of mucus, bloating, or a feeling of abdominal distension
排除标准
- •Previous allergy to mosapride
- •Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
- •Age < 18 years
- •History of bloody stools or melena
- •Diarrhea (>3 bowel movements per day)
- •Constitutional symptoms (fever, weight loss)
- •Severe constipation (< 1 bm/week)
- •Pregnancy or lactation
- •Patients with history of cardiac arrhythmias
- •QT prolongation on baseline ECG
- •Chronic laxative use and dependence
- •Patients with previous history of congenital heart disease
- •Patients with previous history of hypokalemia or hyperkalemia
- •Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
研究组 & 干预措施
1
Experimental
Mosapride
干预措施: Mosapride Citrate (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
时间窗: Within the first 8 weeks of treatment
次要结局
未报告次要终点
研究者
Nabil Mansour
assistant professor
American University of Beirut Medical Center
研究点 (1)
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