NCT02481947已完成3 期
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Braintree Laboratories50 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2015年5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
- 459
- 试验地点
- 50
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) Response
研究概览
简要总结
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone 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
- Double (Participant, Investigator)
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:
- •A. 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
- •B. Loose stools are rarely present without the use of laxatives
- •C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements
- •Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- •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
- •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 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 Visit 5
- •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 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
- •Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
研究组 & 干预措施
BLI400 Laxative
Experimental
21 gm BLI400 powder
干预措施: BLI400 Laxative (Drug)
Lubiprostone
Active Comparator
24 mcg capsule bid
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) Response
时间窗: 12 weeks
The primary endpoint is based on the number 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 (50)
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