Efficacy and Safety Study of Esomeprazole vs Omeprazole t... | NCT00402259

Studies
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding

NCT00402259

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 12, 2009Estimated

Enrollment

440Estimated

Phase

Phase 3

Conditions

Gastrointestinal Hemorrhage

Interventions

Esomeprazole IV
Omeprazole IV

Countries

China

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 PUB

Status Module

Record Verification Date

Mar 2009

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

Aug 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Nov 17, 2006

First Submission Date that Met QC Criteria

Nov 17, 2006

First Posted Date

Nov 22, 2006Estimated

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

Mar 11, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

440Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment

Secondary Outcomes

Measure	Description	Time Frame
Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Time to absence of clinically significant upper GI bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18-65 years.
GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
One endoscopically confirmed bleeding peptic ulcer or erosive gastritis

Exclusion Criteria:

GI bleeding caused by Esophageal varices
Mallory Weiss syndrome
Zollinger-Ellison syndrome
Suspicion of gastric malignancy at baseline endoscopy
Post-Billroth-resection
Unknown source of GI bleeding · 2.Unstable vital signs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tore Lind, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Fuzhou	Fujian		China
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole IV	Drug
Omeprazole IV	Drug