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Esomeprazole vs Famotidine for Stress Ulcer Prophylaxis in Neurosurgical ICU
NCT00633035Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2007
- Primary completion
- Mar 2010
- Countries
- 1
- Sponsor
- Far Eastern Memorial Hospital
- Modality
- Small Molecules
- Drugs
- esomeprazole
- Conditions
- stress ulcer
01
Overview
Phase 4, randomised, open-label trial of esomeprazole in stress ulcer (2 arms), sponsored by Far Eastern Memorial Hospital. Primary endpoint: Overt Upper Gastrointestinal Bleeding at 7 days. Started Sep 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Esomeprazole
Esomeprazole 40 mg qd via NG or orally
Famotidine
Famotidine 20 mg IV bolus q12h
03
Who it enrols
Adult patients admitted to the Neurosurgical ICU within 24 hours after neurosurgery with ventilator support, excluding those with GI bleeding or unsuitable for NG route.
04
Endpoints
Primary
Overt Upper Gastrointestinal Bleeding
Secondary
Ventilator Associated Pneumonia
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