NCT02819297已完成3 期
BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Braintree Laboratories51 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,020
- 试验地点
- 51
- 主要终点
- Treatment Response
研究概览
简要总结
The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus 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
- •Male or female subjects at least 18 years of age
- •Constipated, defined by the following adapted ROME II definition
- •Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
- •Straining during > 25% of defecations
- •Lumpy or hard stools in > 25% of defecations
- •Sensation of incomplete evacuation for > 25% of defecations
- •If female, and of child-bearing potential, is using an acceptable form of birth control
- •Negative serum 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
- •Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
- •Meet the Rome II criteria for Irritable Bowel Syndrome.
- •Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- •Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
- •Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
- •Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
- •Subjects who are pregnant or lactating, or intend to become pregnant during the study
- •Subjects of childbearing potential who refuse a pregnancy test
- •Subjects who are allergic to any study medication component
- •Subjects taking narcotic analgesics or other medications known to cause constipation
- •Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
- •Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
- •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
- •Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
- •Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
研究组 & 干预措施
BLI400 Laxative
Experimental
BLI400 Laxative
干预措施: BLI400 Laxative (Drug)
Placebo
Placebo Comparator
BLI400 placebo
干预措施: BLI400 Placebo (Drug)
结局指标
主要结局
Treatment Response
时间窗: 12 weeks
The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
次要结局
未报告次要终点
研究者
研究点 (51)
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