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

This study has been completed.

First Received: January 29, 2007 Last Updated: March 10, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00428701

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
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:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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:	July 2007

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

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
Nashville, Tennessee, United States
Research Site
Memphis, Tennessee, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mark Sostek, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00107, Nexium IV ICU Study 107
Study First Received:	January 29, 2007
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00428701 History of Changes
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:

Stomach Ulcer
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

Pathologic Processes
Digestive System Diseases
Stomach Diseases
Critical Illness
Therapeutic Uses
Anti-Ulcer Agents
Peptic Ulcer

ClinicalTrials.gov processed this record on February 08, 2010