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

Heartburn Clinical Trial

— Synchronise  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524329
• Other study ID #: N13
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: September 25, 2008
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: October 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heartburn

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca