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CompletedNCT00325715Updated Jun 2, 2011

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

A Phase 1 interventional study of AGN 201904 and esomeprazole in Peptic Ulcer, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-02.

Sponsored by Allergan · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Peptic Ulcer

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03

In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's enrollment of 150 is close to the median of 150 across 142 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Adult Volunteers who have provided written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
150 participants (actual)

Study arms

  • Experimental
    1

    Drug: AGN 201904

  • Active comparator
    2

    Drug: esomeprazole

Interventions

  • DrugAGN 201904
  • Drugesomeprazole
06

What researchers measure

Primary outcomes

  1. Stomach or upper intestinal erosions

07

Study locations

1 site
  • Houston, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00325715
Lead sponsor
Allergan
First posted
May 15, 2006
Start date
Apr 2006
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Jun 2, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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