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

NCT ID: NCT00524329

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Heartburn

Keywords

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upper GI-symptoms heartburn NSAID risk PPI Bloating Regurgitation

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Andrea Sellink

Role: STUDY_DIRECTOR

AstraZeneca

N van den Berk

Role: STUDY_CHAIR

AstraZeneca

Countries

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Netherlands

Other Identifiers

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N13

Identifier Type: -

Identifier Source: org_study_id