NCT00524329

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

August 29, 2007

Last Update Submit

September 25, 2008

Conditions

Heartburn

Keywords

upper GI-symptomsheartburnNSAIDriskPPIBloatingRegurgitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting at general practitioner

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HeartburnGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Andrea Sellink

    AstraZeneca

    STUDY DIRECTOR

  • N van den Berk

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2007

First Posted

September 3, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

October 1, 2007

Last Updated

September 26, 2008

Record last verified: 2008-09