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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole Sodium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No