Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Colonic transit (as measured by GC24)
研究概览
简要总结
The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.
详细描述
The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Colonic transit (as measured by GC24)
次要结局
- Ascending colon emptying t1/2
- Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time
- Average number of stools per day before and during treatment
- Colonic transit (GC48)
- Gastric emptying time (1, 2, 4 hours, thalf)