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
- 发起方
- 入组人数
- 1,559
- 试验地点
- 109
- 主要终点
- Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
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).
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 LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or
- •completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811]
- •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 AE or a clinically significant finding on a physical examination, 12-lead ECG, 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 in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
干预措施: Linaclotide (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
次要结局
未报告次要终点