Postoperative Ileus (Post Cardiac Surgery Constipation)Phase 3TRANSITNCT04433390
Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery
A Phase 3 study testing Naloxegol and inert tablet in people with Postoperative Ileus (Post Cardiac Surgery Constipation), run by CMC Ambroise Paré at 1 site in France.
Trial summary
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity. Naloxegol is a peripheral opioid receptor antagonist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus (Post Cardiac Surgery Constipation)
- What is being tested?
- Naloxegol and inert tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2020to 3 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity.
Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery.
The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.
Read the detailed description
Digestive complications following cardiac surgery, such as paralytic ileus and Ogilvie syndrome, are frequent and worsen the prognosis of patients. They pose a real problem of care in intensive care, inducing morbidity and mortality, extended hospital stay and a significant post-operative cost.
Few treatments are effective to reduce transit recovery time, except the neostigmine which has a serious side effects including cardiac ones.
During cardiac surgery, opioid treatments are frequently used to relieve the pain like sternotomy pain.
The pharmacologic effect of opioid induces the postoperative uleus. Opioid receptors are distributed in the central nervous system, where they are involved in the perception of pain, and in the peripheral nervous system, especially in the mesenteric nervous system, where they regulate intestinal peristalsis.
Morphine receptors antagonist are a target for prevention and treatment of post operative ileus syndrome such as alvimopan and naloxone.
A therapeutic trial demonstrates a decrease in the rate of pneumonia in intensive care patient mechanically ventilated who received naloxone.
Naloxegol is a peripheral antagonist of opioid receptor, from the alvimopan family. It has been designed to antagonize the peripheral, but not central, effects of opioids at therapeutic doses. Naloxegol is a substrate for cytochrome P450 (CYP 3A4). Following oral administration, naloxegol is absorbed rapidly, with peak concentrations achieved at less than 2 hours.
After once daily administration, plasma concentration equilibrium is reached within 2-3 days with minimal accumulation.
The main route of elimination for naloxegol is hepatic. Naloxegol has been shown to be effective in randomized trials of chronic opioid induced constipation, but there is no data on its use in the postoperative ileus.
Research hypothesis: the addition of naloxegol in pre and postoperative cardiac surgery could reduce the time to transit recovery and the rate of digestive and respiratory complications.
- Being tested
- Naloxegol, inert tablet
- Keywords
- Opioid induced constipation, cardiac surgery, transit recovery
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxegolDrug
one naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
inert tabletDrug
one inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Naloxegol group | Experimental | naloxégol tablet by oral route Receives: Drug: Naloxegol |
| Placebo group | Placebo comparator | inert tablet by oral route Receives: Drug: inert tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery
Time (hour) to transit recovery after cardiac surgery
Measured: 5 days
Secondary outcomes (6)
Incidence of digestive complications
rate of digestive complications
Measured: 30 days
Evaluate the effect of the administration of Naloxegol on respiratory complications
rate of respiratory complications
Measured: 30 days
Evaluate the effect of the administration of Naloxegol on infectious complications
rate of infectious complications
Measured: 30 days
Verify the effectiveness of analgesia
Pain Visual Analogue Scale (VAS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Measured: day 1, day2, day3
Compare the length of hospital stay
Duration of hospital stay (days)
Measured: 30 days
Compare the length of ICU stay
Duration of ICU stay (days)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start14 Oct 2020
- Primary completion28 Jan 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Ileus (Post Cardiac Surgery Constipation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433390
- Sponsor's protocol ID
- 2019/09
- Acronym
- TRANSIT
- Status last verified
- May 2026
- First submitted
- 12 Jun 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laghlam D, Gibert H, Merzoug M, Leclerc D, Coroyer L, Estagnasie P, Squara P, Nguyen LS, Geri G. Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101498. doi: 10.1016/j.accpm.2025.101498. Epub 2025 Feb 21.
PubMed 39988233
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
- ClinicalTrials.gov ID
- NCT04433390
- Acronym / sponsor ID
- TRANSIT / 2019/09
- Keywords
- Opioid induced constipation, cardiac surgery, transit recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity.
Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery.
The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.
Detailed description
Digestive complications following cardiac surgery, such as paralytic ileus and Ogilvie syndrome, are frequent and worsen the prognosis of patients. They pose a real problem of care in intensive care, inducing morbidity and mortality, extended hospital stay and a significant post-operative cost.
Few treatments are effective to reduce transit recovery time, except the neostigmine which has a serious side effects including cardiac ones.
During cardiac surgery, opioid treatments are frequently used to relieve the pain like sternotomy pain.
The pharmacologic effect of opioid induces the postoperative uleus. Opioid receptors are distributed in the central nervous system, where they are involved in the perception of pain, and in the peripheral nervous system, especially in the mesenteric nervous system, where they regulate intestinal peristalsis.
Morphine receptors antagonist are a target for prevention and treatment of post operative ileus syndrome such as alvimopan and naloxone.
A therapeutic trial demonstrates a decrease in the rate of pneumonia in intensive care patient mechanically ventilated who received naloxone.
Naloxegol is a peripheral antagonist of opioid receptor, from the alvimopan family. It has been designed to antagonize the peripheral, but not central, effects of opioids at therapeutic doses. Naloxegol is a substrate for cytochrome P450 (CYP 3A4). Following oral administration, naloxegol is absorbed rapidly, with peak concentrations achieved at less than 2 hours.
After once daily administration, plasma concentration equilibrium is reached within 2-3 days with minimal accumulation.
The main route of elimination for naloxegol is hepatic. Naloxegol has been shown to be effective in randomized trials of chronic opioid induced constipation, but there is no data on its use in the postoperative ileus.
Research hypothesis: the addition of naloxegol in pre and postoperative cardiac surgery could reduce the time to transit recovery and the rate of digestive and respiratory complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naloxegol group | Experimental | Drug: Naloxegolnaloxégol tablet by oral route |
| Placebo group | Placebo comparator | Drug: inert tabletinert tablet by oral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxegolone naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days. | Drug | Naloxegol group |
| inert tabletone inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days. | Drug | Placebo group |
Primary outcome
Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery
Time frame: 5 days
Time (hour) to transit recovery after cardiac surgery
6 secondary outcomes
Incidence of digestive complications
Time frame: 30 days
Evaluate the effect of the administration of Naloxegol on respiratory complications
Time frame: 30 days
Evaluate the effect of the administration of Naloxegol on infectious complications
Time frame: 30 days
Verify the effectiveness of analgesia
Time frame: day 1, day2, day3
Compare the length of hospital stay
Time frame: 30 days
Compare the length of ICU stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 39988233Laghlam D, Gibert H, Merzoug M, Leclerc D, Coroyer L, Estagnasie P, Squara P, Nguyen LS, Geri G. Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101498. doi: 10.1016/j.accpm.2025.101498. Epub 2025 Feb 21.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naloxegol and inert tablet in people with Postoperative Ileus (Post Cardiac Surgery Constipation), run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.