The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices...
Date First Received: April 26, 2006
Last Updated: April 9, 2008
Verified by: AstraZeneca, April 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 1000
Brief Summary
Official Title: “Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care”
Condition Keyword(s):
Intervention(s):
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Esomeprazole
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Villy Meineche Schmidt, MD Principal Investigator Charlottenlund Research Site
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00318968
Study ID Number: D9612L00076
ClinicalTrials.gov Identifier: NCT00318968
Health Authority: Denmark: Danish Medicines Agency
Clinical Trials Authorship and Review
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