Back to resultsAn Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
Primary Purpose
Gastric Ulcer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Ulcer focused on measuring stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
Eligibility 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
Sites / Locations
- Research SIte
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary Outcome Measures
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00428701
Brief Title
An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer
Keywords
stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole Sodium
Primary Outcome Measure Information:
Title
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary Outcome Measure Information:
Title
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sostek, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research SIte
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20230209
Citation
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.
Results Reference
derived
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An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
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