Who is sponsoring NCT04433390?

NCT04433390 is sponsored by CMC Ambroise Paré.

What drugs are being tested in NCT04433390?

Interventions in NCT04433390: Naloxegol, inert tablet.

What condition does NCT04433390 study?

NCT04433390 studies Postoperative Ileus (Post Cardiac Surgery Constipation).

Is NCT04433390 still recruiting?

NCT04433390 is currently completed. Last updated 8 March 2022.

Last reviewed 2022-03-08 · How we verify

NCT04433390: TRANSIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

Completed Phase 3 Last updated 8 March 2022

What this trial tests

Phase 3 trial testing Naloxegol in Postoperative Ileus (Post Cardiac Surgery Constipation) in 305 participants. Completed in 3 March 2022.

Timeline

14 October 2020

Primary endpoint
28 January 2022

3 March 2022

Quick facts

Lead sponsor	CMC Ambroise Paré
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	305
Start date	14 October 2020
Primary completion	28 January 2022
Estimated completion	3 March 2022
Sites	1 location across France

Drugs / interventions tested

Naloxegol (NALOXEGOL) — full drug profile →
inert tablet — full drug profile →

Conditions studied

Postoperative Ileus (Post Cardiac Surgery Constipation) — all drugs for Postoperative Ileus (Post Cardiac Surgery Constipation) →

Sponsor

CMC Ambroise Paré — full company profile →

Who can join

18 and older, any sex, with Postoperative Ileus (Post Cardiac Surgery Constipation). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial.
Laghlam D, Gibert H, Merzoug M, Leclerc D, et al · · 2025 · PMID 39988233 · DOI 10.1016/j.accpm.2025.101498

Verify or expand the search:

Other trials of Naloxegol

Trials testing the same drug.

NCT05008926 — The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injure · Phase 3 · recruiting
NCT03720613 — Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation · recruiting
NCT04294550 — Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol · completed
NCT03638440 — Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC. · completed
NCT05770960 — Colonic Motor Patterns in Healthy Volunteers · Phase 4 · completed

Other CMC Ambroise Paré trials

Trials by the same sponsor.

NCT07477730 — Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty. · NA · not yet recruiting
NCT07345559 — Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock · NA · recruiting
NCT07332949 — Impact of Dialysis on Sexuality. · recruiting
NCT06777355 — Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Sur · completed
NCT06327334 — Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04433390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CMC Ambroise Paré
Last refreshed: 8 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04433390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing