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

AstraZeneca491 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

491

Conditions

Gastric Acid Suppression Proton Pump Inhibitors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Research Site

Berat, Albania

Research Site

Burrel, Albania

Research Site

Durrës, Albania

Research Site

Elbasan, Albania

Outcomes

Primary Outcomes

Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

Time frame: Day 0

Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

Time frame: Week 2-4

Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

Time frame: Weeks 8-12

Secondary Outcomes

To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

Time frame: 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.

Time frame: Once: Day 0

Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.

Time frame: Day 0

To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

Time frame: Weeks 2-4

To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

Time frame: Weeks 8-12

Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.

Time frame: Weeks 2-4

Data from ClinicalTrials.gov

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