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

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ClinicalTrials.gov Identifier: NCT00428701
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Gastric Ulcer Drug: Esomeprazole Sodium Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects

Secondary Outcome Measures :
  1. The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428701


Locations
United States, Delaware
Research SIte
Newark, Delaware, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00428701     History of Changes
Other Study ID Numbers: D9612L00107
Nexium IV ICU Study 107
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
stress ulcer
critically ill
gastric acid
gastric aspirates
esomeprazole

Additional relevant MeSH terms:
Critical Illness
Stomach Ulcer
Disease Attributes
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action