Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Assessment of Quality of Life
研究概览
简要总结
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.
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
- •Diagnosis of Cancer
- •Treatment with opioids
- •OIC symptoms
- •Inadequate response to laxatives
- •Karnofsky equal or above 50
- •Ambulatory
- •Must be able to complete questionnaire forms
排除标准
- •at the start of the study:
- •Hypersensitivity to Naloxegol or vehicle
- •Suspicion or high risk of gastrointestinal block
- •High risk of GI perforation
- •Severe liver failure
- •Pregnancy or breastfeeding
- •Use of potent CYP3A4 inhibitors
- •Cognitive impairment
研究组 & 干预措施
Experimental
Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.
干预措施: Naloxegol (Drug)
结局指标
主要结局
Assessment of Quality of Life
时间窗: 12 months
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
次要结局
- Assessment of Constipation Symptoms(6 months)