NCT00832650终止1 期
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Colonic Transit at 24 Hours
研究概览
简要总结
To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects
排除标准
- •Evidence or history of clinically significant findings at screening
研究组 & 干预措施
Fesoterodine
Experimental
Tablets
干预措施: fesoterodine fumarate (Drug)
Placebo
Placebo Comparator
Tablets
干预措施: placebo (Drug)
Solifenacin
Active Comparator
Tablets
干预措施: solifenacin (Drug)
结局指标
主要结局
Colonic Transit at 24 Hours
时间窗: Day 13 (Day 12 24 hours post-meal)
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \*1 + % TC \*2 + % DC \*3 + % RS \*4 + % stool \* 5 ) divided by 100.
次要结局
- Proximal Colonic Emptying Time(Day 12 to 14)
- Colonic Transit at 48 Hours(Day 14 (Day 12 48 hours post-meal))
- Colonic Filling at 6 Hours(Day 12)
- Time to Gastric Emptying(Day 12: 2 hours, 4 hours)
- Mean Number of Stools Per Day(Day 11 to 13)
- Mean Score of Stool Consistency Per Day(Day 11 to 13)
- Average Score of Ease of Passage During Defecation Per Day(Day 11 to 13)
- Mean Proportion of Bowel Movements With Satisfaction Per Day(Day 11 to 13)
研究者
研究点 (1)
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