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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Esomeprazole
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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014