NCT02822508已完成2 期
A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Braintree Laboratories73 个研究点 分布在 1 个国家目标入组 434 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
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 434
- 试验地点
- 73
- 主要终点
- % of Subjects With Treatment Response
研究概览
简要总结
The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages of > 18 and < 85 years
- •Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
- •Straining during > 25% of defecations
- •Lumpy or hard stools in > 25% of defecations
- •Sensation of incomplete evacuation for > 25% of defecations
- •Receiving a stable maintenance opioid regimen.
- •If female, and of child-bearing potential, is using an acceptable form of birth control
- •Negative pregnancy test at screening (Visit 1), 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 or toxic megacolon
- •Subjects who have had major surgery within 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
- •Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
- •Absence of a structural or biochemical explanation for the abdominal pain symptom
- •At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
- •i. Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.
- •Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
- •Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
- •Subjects who are pregnant or nursing, or intend to become pregnant during the study
- •Subjects of childbearing potential who refuse a pregnancy test
- •Subjects who are allergic to any BLI801 component
- •Subjects taking non-opioid medications or supplements known to cause constipation
- •Subjects with an active history of drug or alcohol abuse
- •Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- •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 had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
- •Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
研究组 & 干预措施
BLI801 Laxative (high dose)
Experimental
BLI801 Laxative (high dose)
干预措施: BLI801 Laxative (Drug)
BLI801 Laxative (mid dose)
Experimental
BLI801 Laxative (mid dose)
干预措施: BLI801 Laxative (Drug)
BLI801 Laxative (low dose)
Experimental
BLI801 Laxative (low dose)
干预措施: BLI801 Laxative (Drug)
BLI801 Placebo
Placebo Comparator
BLI801 Placebo
干预措施: BLI801 Placebo (Drug)
结局指标
主要结局
% of Subjects With Treatment Response
时间窗: 12 weeks
Treatment response is defined as 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 spontaneous bowel movements (SBMs) and an increase from baseline of \> 1 SBM in that week.
次要结局
未报告次要终点
研究者
研究点 (73)
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