An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,272
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Related Adverse Events.
研究概览
简要总结
Multi-center, open-label, long-term safety study
详细描述
This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.
Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.
Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.
Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented diagnosis of IBS-C who:
- •Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
- •Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.
排除标准
- •Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
- •Female patient of childbearing potential with a positive urine pregnancy test on Day
- •Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
- •Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
- •In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.
研究组 & 干预措施
Plecanatide
Plecanatide 6.0 mg tablets
干预措施: Plecanatide (Drug)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events.
时间窗: up to 53 weeks
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
次要结局
未报告次要终点