NCT00139568已完成3 期
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese 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
- 600
- 试验地点
- 2
- 主要终点
- Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
研究概览
简要总结
Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women
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
- •Men or women at least 18 years of age
- •History of constipation for at least 6 months prior to screening
- •Normal bowel evaluation performed within the past 5 years
排除标准
- •Most bothersome symptom in last 6 months is abdominal pain/discomfort
- •Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy
- •Insulin dependent diabetes
- •Evidence of cathartic colon or laxative abuse
- •Other inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
次要结局
- Safety
- Response rate for CSBM during the first 4 weeks of treatment
- Patients' daily assessment of bowel habits
- Patients' weekly assessment of constipation symptoms
- Satisfactory relief of CC symptoms
- PAC-QoL questionnaire
- PPSM questionnaire
研究者
研究点 (2)
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