Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 10
- 主要终点
- To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
研究概览
简要总结
This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.
详细描述
The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
The primary safety end point is the incidence of adverse events leading to study discontinuation.
The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.
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
- •Patient ≥ 18 years old
- •Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
- •Patient with opioid-induced constipation
- •Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
- •Signing of the informed consent
排除标准
- •Patients with colorectal cancer
结局指标
主要结局
To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
时间窗: 4 week treatment period
Response rate
次要结局
- Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment(4 week observation period)
- Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).(4 week observation period)
- Time to the first post-dose bowel movement(4 week observation period)
- Change in Patient Assessment of Constipation (PAC-QOL)(4 week observation period)
- Incidence of overall adverse events, including SAEs(4 week observation period)
- Change in stool consistency(4 week observation period)
- Analgesic treatment interruptions/dose adjustments(4 week observation period)
- Naloxegol treatment interruptions/dose adjustments(4 week observation period)
- Patient satisfaction (PGI-I)(4 week observation period)