Nexium RESPONSE Trial

Phase 4

Completed

• Conditions: GERD

• Registration Number: NCT00318968
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Study Start: 2006-05
• Study Completion: 2007-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-23
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent

Exclusion Criteria

• Alarm symptoms
• Pregnancy
• Contraindications to Nexium

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.

Secondary Outcome Measures

Name	Time	Method
To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).

Trial Locations

Locations (1)

Research Site; 🇩🇰 Viby J, Denmark