NCT00325715

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

May 11, 2006

Last Update Submit

June 1, 2011

Conditions

Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • Stomach or upper intestinal erosions

Study Arms (2)

1

EXPERIMENTAL
Drug: AGN 201904

2

ACTIVE COMPARATOR
Drug: esomeprazole

Interventions

AGN 201904DRUG
1
esomeprazoleDRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Adult Volunteers who have provided written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

AGN 201904Esomeprazole

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 15, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

June 2, 2011

Record last verified: 2011-06

Locations

US(1)