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

Phase 4

Completed

• Conditions: Gastric Ulcer

• Registration Number: NCT00428701
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2007-01-29
• Study First Submitted QC: 2007-01-29
• Study First Posted: 2007-01-30
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Research Site; 🇺🇸 Nashville, Tennessee, United States

Research SIte; 🇺🇸 Newark, Delaware, United States