TerminatedNot Applicable

Naloxegol Health Outcome Post Authorisation Safety Study

Stopped: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023

Netherlands, United Kingdom10,000 participantsStarted 2016-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence (yes/no) of bowel perforation

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT02813369

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11

View on ClinicalTrials.gov More Opioid Induced Constipation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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

What they're measuring

Presence (yes/no) of bowel perforation

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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