Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

Study Overview
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Brief Summary
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This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.

Official Title
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A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

Conditions
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Gastric Acid Suppression, Proton Pump Inhibitors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have had upper GI symptoms requiring acid suppression treatment Treatment with Nexium is in accordance with indications and dosing approved in Albania. Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed. Exclusion Criteria: Known hypersensitivity to Nexium or any other constituents of the formulation Concomitant administration of atazanavir and nelfinavir. Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. |  | Day 0 | 
| Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. |  | Week 2-4 | 
| Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. |  | Weeks 8-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. |  | Day 0 | 
| Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania. |  | Once: Day 0 | 
| Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. |  | Day 0 | 
| To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. |  | Weeks 2-4 | 
| To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. |  | Weeks 8-12 | 
| Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. |  | Weeks 2-4 | 
| Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. |  | Weeks 8-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, gastric and duodenal ulcers, NSAID therapy