The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.

The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients. - NIPA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000959-14-FR

Enrollment

370

Registered

2020-12-24

Start date

2021-03-16

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevent opioids induced gastrointestinal motility disturbance in brain Injured Patients. MedDRA version: 20.1 Level: PT Classification code 10061173 Term: Gastrointestinal motility disorder System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 21.1 Level: PT Classification code 10042316 Term: Subarachnoid haemorrhage System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10078809 Term: Skull trauma System Organ Class: 10

Interventions

Trade Name: MOVENTIG® (Naloxégol) 25 mg Product Name: MOVENTIG® (Naloxégol) 25 mg Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Nasogas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

France

Contacts

Public ContactDRCI

CHRU de Brest

promotion-interne@chu-brest.fr+3329020110

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026