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

January 21, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Mark Sostek, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612L00107
  • Nexium IV ICU Study 107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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