NCT00141089已完成3 期
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,026
- 主要终点
- Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
研究概览
简要总结
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.
The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.
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
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
- •A 6-month history of constipation defined as <3 complete spontaneous bowel movements per week and >1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining
排除标准
- •Patients with cancer, inflammatory bowel disease or other structural bowel disease
- •Past or current diagnosis of irritable bowel syndrome were excluded.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
次要结局
- For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
- Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
- Safety and tolerability.
研究者
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