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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 (Synchronise)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00524329
First received: August 29, 2007
Last updated: September 25, 2008
Last verified: September 2008
History of Changes
  Purpose

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).


Condition
Heartburn

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:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

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)
  Eligibility

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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524329

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

No publications provided

Responsible Party: Tore Lind / Medical Science Director, AstraZeneca
ClinicalTrials.gov 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
heartburn
NSAID
risk
 PPI
Bloating
Regurgitation

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013