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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: August 29, 2007
Last updated: September 25, 2008
Last verified: September 2008
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).


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Estimated Enrollment: 1220
Study Start Date: January 2006
Study Completion Date: October 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting at general practitioner

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
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Please refer to this study by its identifier: NCT00524329

Sponsors and Collaborators
Study Director: Andrea Sellink AstraZeneca
Study Chair: N van den Berk AstraZeneca
  More Information

Responsible Party: Tore Lind / Medical Science Director, AstraZeneca Identifier: NCT00524329     History of Changes
Other Study ID Numbers: N13 
Study First Received: August 29, 2007
Last Updated: September 25, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
upper GI-symptoms

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Ulcer Agents
Antirheumatic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents processed this record on May 26, 2016