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

September 25, 2008 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting at general practitioner

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Andrea Sellink, AstraZeneca
  • Study Chair: N van den Berk, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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