An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,743
- 试验地点
- 1
- 主要终点
- Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).
详细描述
Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have
- •entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
- •completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
- •Sexually active patients of childbearing potential agree to use birth control
- •Females of childbearing potential must have a negative urine pregnancy test prior to dosing
- •Lactating females must agree not to breastfeed
- •Patient must meet protocol criteria for CC or IBS-C
排除标准
- •Patient must not use protocol-defined prohibited medicine
- •Patient is planning to receive an investigational drug at any time during the study
- •Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test
研究组 & 干预措施
Linaclotide
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
干预措施: Linaclotide (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: From first dose of open-label study drug up to 78 weeks
For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.
次要结局
未报告次要终点