NCT02665728已完成2 期
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
Braintree Laboratories3 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年12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
- 33
- 试验地点
- 3
- 主要终点
- Treatment Response
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at between 12-17 years of age
- •Weight more than 40 kg (88 lbs.).
- •Constipated, defined by the following criteria
- •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
- •Loose stools are rarely present without the use of laxatives
- •There are insufficient criteria for irritable bowel syndrome - 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 12 weeks 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 (hormonal birth control, intrauterine device, double-barrier method, depot contraceptive, sterilized, or abstinence)
- •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 3
- •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 the study medication
- •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
- •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
Experimental
BLI400 Laxative
干预措施: BLI400 Laxative (Drug)
结局指标
主要结局
Treatment Response
时间窗: 4 weeks
Overall treatment response is defined as weekly response in at least 2 out of 4 weeks. Weekly response is defined as greater than or equal to 3 spontaneous bowel movements during a week.
次要结局
未报告次要终点
研究者
研究点 (3)
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