An Open-label, Exploratory Trial to Assess Gastric Acid C... | NCT00428701

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

NCT00428701

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 24, 2011Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Gastric Ulcer

Interventions

Esomeprazole Sodium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Nexium IV ICU Study 107

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Jan 29, 2007

First Submission Date that Met QC Criteria

Jan 29, 2007

First Posted Date

Jan 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2011

Last Update Posted Date

Jan 24, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole Sodium	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Sostek, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research SIte		Newark	Delaware		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20230209	Derived	Metz DC, Fulda GJ, Olsen KM, Monyak JT, Simonson SG, Sostek MB. Intravenous esomeprazole pharmacodynamics in critically ill patients. Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer
D016638	Critical Illness

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds