An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Presence (yes/no) of stroke
研究概览
简要总结
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.
详细描述
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in the indicated population, grouped by cancer or non-cancer, and within at-risk vulnerable non-cancer populations identified in the naloxegol risk management plan (RMP) by describing type and frequency of identified and potential risks (including bowel perforation, acute MI, stroke, CV-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.
The primary objective of the study is to assess the incidence risk of bowel perforation, acute MI, stroke, all-cause mortality, and hypertension in patients treated with naloxegol (Naloxegol Inception Cohort, (NIC)), grouped by cancer or non cancer, a Concurrent Reference Cohort (CRC) by cancer or non-cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior CV, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of cytochrome P450 (CYP) 3A inhibitors/inducer or P-glycoprotein (Pgp) modulators.
An exploratory objective of the study is to assess the incidence risk of CV-specific mortality, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity in patients treated with naloxegol (NIC) grouped by cancer and non cancer, a CRC grouped by cancer or non cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior cardiovascular risk, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of CYP3A inhibitors/inducer or Pgp modulators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.)
排除标准
- •Patients <18 years of age on cohort entry date
- •Patients with <1 year of continuous data available prior to cohort entry date
- •Patients without exposure to current regular opioid use defined by >30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date
- •Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date
- •Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date
研究组 & 干预措施
naloxegol
patients exposed to naloxegol
干预措施: naloxegol (Drug)
non-PAMORA laxative
patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative
干预措施: non-PAMORA laxative (Drug)
结局指标
主要结局
Presence (yes/no) of stroke
时间窗: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for cerebral, cerebellar haemorrhage or infarction, cerebral embolism, stroke or cerebrovascular accident
Presence (yes/no) of bowel perforation
时间窗: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic or procedure code
Presence (yes/no) of acute MI
时间窗: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for acute MI, a diagnostic code for electrocardiogram supportive of MI or cardiac enzyme lab tests with positive results
Presence (yes/no) of all-cause mortality
时间窗: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Record of death
Presence (yes/no) of hypertension
时间窗: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a hypertension (HT) diagnostic code where no record of HT or treatment for HT was observed in the baseline, or a record of change in HT treatment type or dose from baseline was observed.
次要结局
- Presence of (yes/no) opioid withdrawal(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) diarrhea(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) CV-specific mortality(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) abdominal pain(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) syncope(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) change in pain severity(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)