[PMS] LINZESS® Tablet 0.25mg Long-term Specified Drug Use-results Survey in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,475
- 试验地点
- 47
- 主要终点
- Incidence of diarrhea
研究概览
简要总结
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
详细描述
This is a post-marketing long-term specified drug use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
排除标准
- 未提供
研究组 & 干预措施
Irritable Bowel Syndrome
Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time
干预措施: linaclotide (Drug)
Chronic Constipation
Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
干预措施: linaclotide (Drug)
结局指标
主要结局
Incidence of diarrhea
时间窗: Up to Week 36
To assess the incidence of diarrhea as a criteria of safety variables.
次要结局
- Efficacy assessed by Global assessment of relief of IBS and constipation symptoms(Up to Week 36)
- Safety assessed by incidence of adverse drug reactions(Up to Week 36)