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

Gastric Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428701
• Other study ID #: D9612L00107
• Secondary ID: Nexium IV ICU St
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2007
• Last updated: January 21, 2011
• Start date: October 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Gastric Ulcer
• Stomach Ulcer

Intervention

Drug:
• Esomeprazole Sodium

Locations

Country	Name	City	State
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Memphis	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research SIte	Newark	Delaware
United States	Research Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary	The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug