An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- Ardelyx
- 入组人数
- 150
- 试验地点
- 45
- 主要终点
- Safety Measure Assessment (Adverse Event)
研究概览
简要总结
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
详细描述
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.
Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥6 and <18 years old at enrollment of either parent study
- •Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
- •Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
- •Subject is ambulatory
- •Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
排除标准
- •Patient discontinued prematurely from the parent study.
- •Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
- •Pregnant or lactating women
- •If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
研究组 & 干预措施
Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose.
干预措施: Tenapanor (Drug)
结局指标
主要结局
Safety Measure Assessment (Adverse Event)
时间窗: 40 weeks
Incidence of AEs, SAEs and drug related adverse events
Safety Measure Assessment (ECG)
时间窗: 40 weeks
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
次要结局
未报告次要终点