NCT00583154已完成2 期
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Braintree Laboratories0 个研究点目标入组 60 人开始时间: 2007年10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
- 60
- 主要终点
- Bowel Movement Count
研究概览
简要总结
To compare the safety and efficacy of BLI-801 administered at 4 dose levels 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
- None
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
- •Male or female subjects at least 18 years of age
- •Constipated according to ROME I criteria
- •Otherwise in good health, as determined by physical exam and medical history
- •If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
- •Negative urine pregnancy test at screening, if applicable
- •In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
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 for the duration of the study
- •Subjects who are pregnant or lactating, or intending to become pregnant during the study
- •Subjects of childbearing potential who refuse a pregnancy test
- •Subjects who are allergic to any BLI-801 component.
- •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
研究组 & 干预措施
4
Experimental
BLI-801 Dose 4
干预措施: BLI-801 (Drug)
1
Experimental
BLI-801 Dose 1
干预措施: BLI-801 (Drug)
2
Experimental
BLI-801 Dose 2
干预措施: BLI-801 (Drug)
3
Experimental
BLI-801 Dose 3
干预措施: BLI-801 (Drug)
结局指标
主要结局
Bowel Movement Count
时间窗: 24 hours
次要结局
- Adverse events(24 hours)
研究者
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