NCT05008926View on ClinicalTrials.gov

The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients

PHASE3RecruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

March 15, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

April 30, 2026

Conditions
Brain Injuries
Interventions
DRUG

Naloxegol

Administration of Naloxegol 25 mg per day by nasogastric tube (SNG) or orogastric tube (SOG). The administration should be started within the first 24 hours after the patient is admitted to intensive care and continued for the duration of the administration of the morphine derivative and until 48 hours after its discontinuation.

DRUG

Placebo

Administration of the placebo according to the same procedures as the experimental arm.

Trial Locations (11)

29609

RECRUITING

CHU Brest, Brest

33000

NOT_YET_RECRUITING

CHU de Bordeaux - Réanimation chirurgicale, Bordeaux

RECRUITING

CHU Bordeaux, Bordeaux

34295

RECRUITING

CHU de Montpellier, Montpellier

37000

ACTIVE_NOT_RECRUITING

CHU Tours - Hôpital BRETONNEAU, Tours

37170

RECRUITING

CHU Tours - Hôpital TROUSSEAU, Tours

44093

RECRUITING

CHU Nantes, Nantes

59000

NOT_YET_RECRUITING

CHU de Lille, Lille

63003

NOT_YET_RECRUITING

CHU Clermont-Ferrand, Clermont-Ferrand

67098

ACTIVE_NOT_RECRUITING

CHU de Strasbourg, Strasbourg

75013

RECRUITING

Hôpital La Pitié Salpétrière (APHP), Paris

All Listed Sponsors
lead

University Hospital, Brest

OTHER