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

Completed

• Conditions: Heartburn

• Registration Number: NCT00524329
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-03
• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Study Completion: 2007-10
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1220

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified