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

AstraZeneca0 sites1,220 target enrollmentJanuary 2006

ConditionsHeartburn

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heartburn
Sponsor: AstraZeneca
Enrollment: 1220
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

October 2007

Last Updated

17 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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