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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00428701
First received: January 29, 2007
Last updated: January 21, 2011
Last verified: January 2011

January 29, 2007
January 21, 2011
October 2006
November 2006   (final data collection date for primary outcome measure)
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Same as current
Complete list of historical versions of study NCT00428701 on ClinicalTrials.gov Archive Site
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Ulcer
Drug: Esomeprazole Sodium
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00428701
D9612L00107, Nexium IV ICU Study 107
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Mark Sostek, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP