CClinicalTrials.gg
CompletedNCT00524329SynchroniseUpdated Sep 26, 2008

Esomeprazole And Symptomatic Response In Patients With Or Without An Elevated Risk For Non-Steroidal Anti-Inflammatory Drug (NSAID)-Associated GI Damage

An observational study in Heartburn, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-26.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,220
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for NSAID-associated GI-damage to those without an elevated risk for NSAID-associated damage (as determined by the treating physician).

02

Conditions studied

  • Heartburn

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Keywords

  • upper GI-symptoms
  • heartburn
  • NSAID
  • risk
  • PPI
  • Bloating
  • Regurgitation
03

In context

Heartburn

99 studies on the registry are indexed under Heartburn; 10 are open to participants now.

This study's planned enrollment of 1,220 is above the median of 728 across 17 observational studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting at general practitioner

Inclusion criteria

  • Patient with upper gastro-intestinal complaints (defined as heartburn and/or regurgitation and/or nausea and/or bloated feeling)and treatment with esomeprazole 20mg once daily is started because of this (consult 1). Upper gastro-intestinal complaints are thought to be related to NSAID use
  • Patient is using an NSAID** with the following conditions:

    • NSAID use has started at least one week before 1st consultation and is expected to be continued unchanged during the coming period (at least until consult 2)
    • NSAID is taken at least 3 days a week

(**)OTC or Prescription NSAID

(**)Conventional NSAID or COX-2 selective NSAID

Exclusion criteria

Exclusion Criteria:

  • Use of a PPI and/or H2RA in the month preceding the study
  • A history of reflux disease, not related to NSAID use
05

Study design

Time perspective
Prospective
Enrollment
1,220 participants (estimated)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00524329
Lead sponsor
AstraZeneca
First posted
Sep 3, 2007
Start date
Jan 2006
Primary completion
Mar 2007
Completion
Oct 2007
Last update
Sep 26, 2008

Study contacts

Andrea Sellink
study director · AstraZeneca
N van den Berk
study chair · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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