Overview

An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Esomeprazole
Criteria
Inclusion Criteria:

- Critically ill male or female subjects 18 years or older who have a baseline gastric
aspirate pH less then or equal to 4

- Subjects admitted to an ICU requiring mechanically ventilated

- Subjects will have at least one additional stress ulcer risk factor

Exclusion Criteria:

- Anticipated use of pre-pyloric enteral feeding after screening until the end of study

- Physician estimated survival of less then 96 hours

- Anticipation of major surgery within 96 hours of study enrollment