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

This study has been completed.

Sponsored by:	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

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

U.S. FDA Resources

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

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

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

Study ID Numbers:	D9612L00107, Nexium IV ICU Study 107
Study First Received:	January 29, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00428701
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

stress ulcer
critically ill
gastric acid
gastric aspirates
esomeprazole

Study placed in the following topic categories:

Stomach Ulcer
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Critical Illness

Ulcer
Omeprazole
Stress
Peptic Ulcer

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009