Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Double-blind placebo-controlled cross-over MRI study to evaluate the effect of naloxegol and codeine on gastrointestinal motility and volumes

This study aims to understand how certain medications influence constipation that can happen when people take strong pain medicines (opioids). We are particularly interested in how a medicine called naloxegol and another called codeine affect your digestive system. Participants will receive different combinations of these medicines and a dummy pill (placebo) over several visits. Researchers will use special scans (like an MRI) to see how quickly food moves through your gut and how much space different parts of your bowel take up, both after you've eaten a meal and after taking a laxative designed to help you go to the toilet. The goal is to see which treatments are most effective in helping with this type of constipation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

Start

16 Sep 2024

Opioid-induced constipation

What is this study about?

This research study is focusing on a common problem called opioid-induced constipation. This is when strong pain medicines, known as opioids, make it difficult for your bowels to move regularly, leading to constipation. It's a real issue for many people who rely on these painkillers.

The study wants to compare a new medicine called naloxegol, an older pain reliever (codeine), and a placebo (a dummy pill with no active medicine) to see how they affect your digestive system. We're curious to see how each of these impacts how food moves through your gut, as well as how different parts of your bowel are affected. This will be checked at different times: first, before taking anything, then after you've eaten a simple meal like oat porridge, and finally after you've taken a mild laxative called bisacodyl. We will be using special scanning equipment, similar to an MRI, to get detailed pictures of your insides and see what's happening.

This kind of study, sometimes called a Phase IV trial, usually happens after a medicine has already been approved for general use. It helps doctors and researchers understand more about how the medicine works in a real-world setting, finding out more about its effects and how it compares to other treatments for conditions like opioid-induced constipation.

Key takeaways

Study examines constipation caused by strong pain relievers (opioids).
Compares a new medicine (naloxegol) with an older one (codeine) and a dummy pill.
Uses special scans to look at how food moves through your gut.
Participation involves multiple visits and taking different medications.
Open to adults aged 18 and over, both men and women.
Aims to improve treatments for opioid-induced constipation.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women. We need people who are experiencing constipation because they are taking strong pain medicines, known as opioids.

There might be other reasons why someone can't join, for example, if they have certain other health conditions or are taking particular medications that could interfere with the study results. The research team will go through all these details with you to make sure the study is a safe and good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you experiencing constipation because you take strong pain medicines (opioids)?
Are you able to attend multiple study visits?
Are you willing to have special scans (like an MRI)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several study visits. During these visits, you'll receive different treatments: sometimes it will be naloxegol with codeine, sometimes codeine with a dummy pill, and sometimes two dummy pills. You won't know which combination you are getting at any time, nor will the study team – this is so we can get the most accurate results.

You'll be asked to take your study medication, which might include tablets and a liquid syrup. You'll also have a standard meal, like oat porridge, at one of your visits, and at another visit, you'll take a laxative. Throughout the study, special scans, similar to MRI scans, will be used to look at your digestive system and see how quickly food moves through your gut. The total duration of your participation, including all visits and follow-ups, will be explained in full by the study team.

Potential risks and benefits

Taking part in this study may offer benefits, such as gaining a better understanding of your own condition and potentially contributing to new knowledge that could help others with opioid-induced constipation in the future. However, there may be some risks or side effects from the medications or procedures, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is opioid-induced constipation?

It's when strong pain medications (opioids) cause problems with your bowel movements, making it hard to go to the toilet regularly.

What is a 'dummy pill'?

A dummy pill, also called a placebo, looks exactly like the real medicine but contains no active ingredients. It helps us compare the effects of the actual medicine fairly.

Will I know which medicine I'm getting?

No, neither you nor the study doctors will know which medicine you are receiving at the time. This is called 'double-blind' and helps ensure the results are unbiased.

What kind of scans will I have?

You will have special scans, similar to an MRI, to get detailed pictures of your digestive system and see how your gut is working.

Can I stop participating if I change my mind?

Yes, you are completely free to leave the study at any point, and it won't affect any of your ongoing medical care.