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

SYNCHRONISE: Esomeprazole 20 mg Once Daily for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs in Dutch General Practice: The Influence of Risk-Factors for NSAID-Associated GI Damage on Sympton Response

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00524329

Acronym

Synchronise

Enrollment

1220

Registered

2007-09-03

Start date

2006-01-31

Completion date

2007-10-31

Last updated

2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heartburn

Keywords

upper GI-symptoms, heartburn, NSAID, risk, PPI, Bloating, Regurgitation

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).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results