AGN 201904 Versus Esomeprazole in the Prevention of Aspir... | NCT00325715

Studies
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers

NCT00325715

Sponsor

Allergan

Status

Completed

Last Update Posted

Jun 2, 2011Estimated

Enrollment

150Actual

Phase

Phase 1

Conditions

Peptic Ulcer

Interventions

AGN 201904
esomeprazole

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

Status Module

Record Verification Date

Jun 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

Apr 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

May 11, 2006

First Submission Date that Met QC Criteria

May 11, 2006

First Posted Date

May 15, 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

Jun 1, 2011

Last Update Posted Date

Jun 2, 2011Estimated

Description Module

Brief Summary

AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or upper intestinal damage following administration of high-dose aspirin in healthy volunteers

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: AGN 201904
2	Active Comparator		Drug: esomeprazole

Name	Type	Description	Arm Group Labels	Other Names
AGN 201904	Drug		1
esomeprazole

Measure	Description	Time Frame
Stomach or upper intestinal erosions

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Adult Volunteers who have provided written informed consent

Exclusion Criteria:

Volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease.
Female volunteers who pregnant, nursing, or planning a pregnancy
Volunteers with a history of drug or alcohol abuse

Accepts Healthy Volunteers

Yes

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

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C532272	AGN 201904
D064098	Esomeprazole

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided