CompletedNot Applicable

Naloxegol Drug Utilization Post Authorisation Safety Study

Germany, Norway, Sweden17,254 participantsStarted 2015-08

Plain-language summary

This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.

Who can participate

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.

Inclusion criteria

. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index 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

discontinuation

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Switching

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Augmentation

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Restart

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Continuous Use

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Dose Change

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Trial details

NCT IDNCT02813148

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Opioid Induced Constipation trials

Who can participate

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.

Inclusion criteria

. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)

What they're measuring

discontinuation

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Switching

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Augmentation

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Restart

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Continuous Use

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Dose Change

Timeframe: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years