DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Ulcer

Intervention: Esomeprazole Sodium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mark Sostek, MD, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

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

Primary outcome: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects

Secondary outcome: The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research SIte, Newark, Delaware, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Hershey, Pennsylvania, United States

Research Site, Memphis, Tennessee, United States

Research Site, Nashville, Tennessee, United States

Additional Information

Starting date: October 2006
Last updated: January 21, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017