Effect of Stress and a Alpha-1 Antagonist on Anorectal Functions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Weekly Rate of Spontaneous Bowel Movements at 4 Weeks
研究概览
简要总结
This study is designed to better understand the effects of effects of stress, relaxation, and a medication alfuzosin on bowel control and emptying in healthy people and patients with bowel problems.
详细描述
Normally, bowel emptying requires relaxation of the anal sphincter (i.e., lowermost end of intestinal tract) and pelvic muscles. Some people cannot relax these muscles normally and experience constipation. Alfuzosin is a medication which is approved to treat bladder but not bowel problems.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects randomized to this arm will receive a single placebo capsule identical to the study drug.
干预措施: Placebo (Other)
Alfuzosin
In Part A, subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
In Part B, only constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.
干预措施: Alfuzosin (Drug)
结局指标
主要结局
Weekly Rate of Spontaneous Bowel Movements at 4 Weeks
时间窗: 4 weeks
A bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours.
Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks
时间窗: 4 weeks
If the subject indicates that the spontaneous bowel movement (SBM) was associated with a sensation of complete bowel emptying, the SBM will be counted as a complete spontaneous bowel movement (CSBM).
次要结局
未报告次要终点