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Heart surgery bowel breakthrough? drug may speed recovery

NCT ID NCT04433390

Symptom relief Sponsor: CMC Ambroise Paré Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether naloxegol, a drug used for constipation caused by painkillers, can help people who had heart surgery recover normal bowel function faster. About 305 adults participated. The goal was to see if taking naloxegol around the time of surgery reduces the time it takes for the bowels to start working again.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

305 people

The number who actually took part.

Started

Oct 2020

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \> 18 years old, * Undergoing cardiac surgery with cardiopulmonary bypass, * For women of child bearing potential without contraception, beta-HCG negative result * Having signed a written informed consent form, * Affiliation to the social security system. Exclusion Criteria: * Allergy or known hypersensitivity to Naloxegol or any of the excipients or any other opioid antagonist * Pregnant or breastfeeding women * Severe hepatic failure, history of cirrhosis * Moderate or severe renal failure (GFR\<60ml/min) * Concomitant treatment with a strong cytochrome P450 3A4 inhibitor * History of acute gastro-intestinal obstruction known or suspected * History of digestive arteritis * Clinically relevant alteration of the blood-brain-barrier * Cancer with increased risk of gastro-duodenal perforation * Disorder that could alter the integrity of the gastrointestinal lining * Regular treatment with laxative drugs * Concomitant treatment with methadone * Patient unable to take a drug by oral route * Patient under protection of the adults (guardianship, curators or safeguard of justice), * Patient included or planning to be included in another research protocol relating to medications.

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Conditions

The condition(s) this trial relates to.

Opioid-Induced Constipation paralytic ileus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative ileus (post cardiac surgery constipation)

Contacts and locations

Locations

  • CMC Ambroise Paré

    Neuilly-sur-Seine, Neuilly Sur Seine, 92200, France