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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Gastric Ulcer

Treatments: Drug: Esomeprazole Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00428701

Nexium IV ICU Study 107

D9612L00107

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)