Esomeprazole in PPI Failures - IMPROVE

Study Overview
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Brief Summary
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The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.

Official Title
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A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks.

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Other PPI marketed in Sweden


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Male or female, aged 18-65 years History of GERD symptoms during, at least, six months prior to enrolment PPI as maintenance treatment during the last 30 days prior to enrolment Heartburn as predominant GERD symptom, as judged by the investigator Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) Exclusion Criteria: Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm, Gastric or duodenal ulcers within the last three months, Malabsorbtion Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable Patients with severe diseases or disorders which may interfere with the conduct of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|
|Drug: Other PPI marketed in Sweden|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients free from heartburn |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire. |  |  | 
| EuroQol 5D questionnaire. |  |  | 
| Quality Assurance of GERD Treatment Questionnaire |  |  | 
| Willingness to pay |  |  | 
| Serious Adverse Events and Discontinuations due to Adverse Events |  |  |