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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00428701

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Ulcer	Drug: Esomeprazole Sodium	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research SIte	Newark	Delaware	United States
2	Research Site	Shreveport	Louisiana	United States
3	Research Site	Hershey	Pennsylvania	United States
4	Research Site	Memphis	Tennessee	United States
5	Research Site	Nashville	Tennessee	United States