Symptom Adapted Therapy in GERD Patients

Study Overview
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Brief Summary
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The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

Official Title
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A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: esomeprazole
* Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Patients who seek medical advice in primary care for symptoms thought to be GERD-related Exclusion Criteria: Clinical GERD diagnosis/treatment within last 3 month History of severe esophagitis (i.e. LA grade C or D) Previous anti-reflux surgery History of drug abuse Female patients who are pregnant or lactating or at risk of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of three different long-term treatment strategies in primary care setting |  |  | 
| To compare treatments separately within different levels of symptom load according to clinical judgement at baseline |  |  | 
| Number of 'treatment failures' used as primary outcome variable. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load |  |  | 
| Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy |  |  | 
| To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy |  |  | 
| To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nexium