NCT01301781已完成2 期
A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Braintree Laboratories4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
研究概览
简要总结
A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Constipated, defined by ROME III definition
- •Subject has < 3 satisfactory BMs during the run-in period
排除标准
- •Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- •Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
- •Subjects who are allergic to any BLI801 component
- •Subjects taking narcotic analgesics or other medications known to cause constipation.
- •Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
- •Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- •Subjects with an active history of drug or alcohol abuse
研究组 & 干预措施
BLI801 laxative
Experimental
BLI801 laxative - oral solution
干预措施: BLI801 (Drug)
Placebo
Placebo Comparator
BLI801 placebo - oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
时间窗: 3 hours
次要结局
- percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose(3 hours)
- serum chemistry(7 days)
研究者
研究点 (4)
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