Naloxegol Health Outcome Post Authorisation Safety Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Kyowa Kirin Pharmaceutical Development Ltd
• Treatments: Cathartics; Laxatives; Naloxegol; Narcotic Antagonists

Criteria

Inclusion Criteria:

1. 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.)

Exclusion Criteria:

1. Patients <18 years of age on cohort entry date

2. Patients with <1 year of continuous data available prior to cohort entry date

3. 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

4. Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date

5. Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date