An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
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
2 other identifiers
interventional
40
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2006
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 29, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2007
CompletedJanuary 24, 2011
January 1, 2011
1 month
January 29, 2007
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary Outcomes (1)
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
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
Related Publications (1)
Metz DC, Fulda GJ, Olsen KM, Monyak JT, Simonson SG, Sostek MB. Intravenous esomeprazole pharmacodynamics in critically ill patients. Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.
PMID: 20230209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Sostek, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2007
First Posted
January 30, 2007
Study Start
October 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01