An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Ulcer
Intervention: Esomeprazole Sodium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Mark Sostek, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary outcome: The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research SIte, Newark, Delaware, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Additional Information
Starting date: October 2006
Last updated: January 21, 2011
|