The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.
Phase 1
- Conditions
- Prevent opioids induced gastrointestinal motility disturbance in brain Injured Patients.MedDRA version: 20.1Level: PTClassification code 10061173Term: Gastrointestinal motility disorderSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 21.1Level: PTClassification code 10042316Term: Subarachnoid haemorrhageSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10078809Term: Skull traumaSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-000959-14-FR
- Lead Sponsor
- CHRU de Brest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method