Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting One or More Adverse Events (AEs)
研究概览
简要总结
The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice.
详细描述
This is a prospective, observational post-marketing surveillance study of lubiprostone in participants with constipation. The study will assess the safety and effectiveness of lubiprostone for its approved indication with real-world setting in South Korea.
The study will enroll approximately 3000 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
• All Participants
The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years. Data collection will be based on routinely scheduled visits during a 12-month follow up period for each participant up to a final follow-up when the participant discontinues treatment or at the end of follow-up period for any participants still taking lubiprostone.
NOTE: This product was divested from Takeda to Jeil in 2022.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •South Korean adult.
- •With constipation caused by:
- •Chronic Idiopathic Constipation (CIC), or
- •Opioid-Induced Constipation (OIC) from treatment for chronic, non-cancer pain, including participants with chronic pain related to prior cancer or its treatment who do not require frequent (example weekly) opioid dosage escalation.
- •Is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation.
排除标准
- •Treated with lubiprostone outside of the locally approved label in South Korea.
- •Participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.
结局指标
主要结局
Number of Participants Reporting One or More Adverse Events (AEs)
时间窗: Up to 12 months
AEs is defined as any undesirable and unintended signs (example, abnormal laboratory values), symptoms, or diseases which occur during or following the administration of the drug, this does not necessarily require causal relationship.
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
时间窗: Up to 12 months
A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
次要结局
- Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment(Baseline up to end of treatment (approximately 12 months))
- Change From Baseline in Frequency of SBM After 12-month Follow up(Up to 12 months)
- Time to Resolution of Symptoms After Treatment Discontinuation(Up to 12 months)