NCT00348634终止4 期
The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
研究概览
简要总结
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & Females aged 65 and older
- •Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
- •Patients must have had a colonoscopy within the past 5 years
- •Patients must pass a balloon expulsion test at screening
- •Patients must be able to comply and understand the use of a diary
排除标准
- •Patients with a clinically significant medical condition that would interfere with the patient completing the trial
- •Patients with loose stools at least once per week
- •Patients with IBS
- •Known allergies to the same class of drug and/or allergies to eggs
- •Patients who require the use of manual maneuvers to have a bowel movement
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
次要结局
- Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy
研究者
研究点 (6)
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