Naloxegol Health Outcome Post Authorisation Safety Study

NCT02813369 | Terminated

• 1 other identifier: D3820R00009
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Opioid Induced Constipation

Outcome Measures

Primary Outcomes (5)

• Presence (yes/no) of bowel perforation

  Presence of a diagnostic or procedure code

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Presence (yes/no) of acute MI

  Presence of a diagnostic code for acute MI, a diagnostic code for electrocardiogram supportive of MI or cardiac enzyme lab tests with positive results

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Presence (yes/no) of stroke

  Presence of a diagnostic code for cerebral, cerebellar haemorrhage or infarction, cerebral embolism, stroke or cerebrovascular accident

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Presence (yes/no) of all-cause mortality

  Record of death

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Presence (yes/no) of hypertension

  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.

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

Secondary Outcomes (6)

• 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) 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) 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) 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) syncope

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

Other Outcomes (14)

• Demographic characteristics

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Time characteristics

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

• Opioid-induced Constipation Characteristics: Prior constipation diagnosis

  Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years

Study Arms (2)

naloxegol

patients exposed to naloxegol

Drug: naloxegol

non-PAMORA laxative

patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative

Drug: non-PAMORA laxative

Interventions

naloxegol DRUG

non-interventional study where patients are exposed to naloxegol during normal clinical practice

naloxegol

non-PAMORA laxative DRUG

non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative

non-PAMORA laxative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the targeted European countries who receive prescriptions for naloxegol will be identified for inclusion in the naloxegol inception cohort, while patients in these countries who receive a prescription for a non-PAMORA laxative will be identified for inclusion in the concurrent reference cohort. All patients in this study will be ≥18 years of age; have ≥1 year of continuous data available; have exposure to current, regular opioid use; and have no prior exposure to PAMORA laxatives alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations).

You may qualify if:

• \. 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Pharmaceutical Development Ltd: lead

Study Sites (2)

Research Site

Utrecht, Netherlands

Location

Research Site

Sutton, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 27, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

NL (1); GB (1)