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
  Purpose

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 Intervention Phase
Gastric Ulcer
Drug: Esomeprazole Sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: January 29, 2007
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014