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

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.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00524329

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

MedlinePlus related topics: Heartburn

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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

Responsible Party:	AstraZeneca ( Tore Lind / Medical Science Director )
Study ID Numbers:	N13
Study First Received:	August 29, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00524329
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

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Signs and Symptoms, Digestive
Heartburn
Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009