Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,028
- 试验地点
- 1
- 主要终点
- Demonstrate the safety of linaclotide therapy
研究概览
简要总结
This is a Multi-center, single arm, observational study to evaluate the safety of linaclotide in IBS-C patients in China. Enrolls approximately 3,000 Chinese patients from 30 participating sites around China and followed up for half year.
详细描述
This is a multi-center, one arm, prospective observational study which enrolls approximately 3,000 Chinese patients in China.The study will be performed under real world clinical practice setting. Patients will be eligible for the study after taking at least one dose of linaclotide. Every patient will be followed maximum of 6 months after enrollment. Study measures will be collected at baseline and during the follow-up period. Incidence of adverse events will be employed to assess the safety and tolerability of linaclotide in Chinese patients. The treatment satisfaction will be employed to assess the impact of treatment. The Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL) will be employed to assess the patient's quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •≧ 18 years old
- •Provision of subject informed consent prior to any study procedures
- •Has taken at least one dose of linaclotide
- •NOT participating in any interventional study currently or during the last 3 months
排除标准
- •If linaclotide is contraindicated according to the product prescribing information
- •Being unable to comply with study-specified procedure
- •Has ever participated in current study before -
结局指标
主要结局
Demonstrate the safety of linaclotide therapy
时间窗: 2023/09/30
The primary objective of current study is to demonstrate the safety of linaclotide therapy by assessment of the incidence of any adverse events (AEs) , serious adverse events (SAEs) , AEs by severity, ADRs and AEs leading to linaclotide-associated interruption, discontinuation, and death during 6-month follow up in Chinese patients.
次要结局
- Assess the impact of linaclotide treatment in patient's quality of life.(2023/09/30)
- Assess the treatment satisfaction(2023/09/30)