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

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.

Completed

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Key information

Conditions

Gastric Ulcer Critical Illness Digestive System Diseases Disease Attributes Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research SIte, Newark, Delaware, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole Sodium

Drug

Primary outcomes

The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects

Secondary outcomes

The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Jan 30, 2007
Registry last updated: Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed