An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Adverse Events in >2% Patients
研究概览
简要总结
This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.
详细描述
During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
- •Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
- •Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
- •Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
排除标准
- •Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
- •The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
- •Pregnant or lactating women
研究组 & 干预措施
50mg BID
Tenapanor, 50 mg BID (100 mg total)
干预措施: Tenapanor (Drug)
结局指标
主要结局
Adverse Events in >2% Patients
时间窗: 52-55 weeks
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams
次要结局
未报告次要终点