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

Completed

• Conditions: Gastric Acid Suppression; Proton Pump Inhibitors

• Registration Number: NCT01130935
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.	Weeks 8-12

Secondary Outcome Measures

Name	Time	Method
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.	Weeks 8-12
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.	Weeks 8-12

Trial Locations

Locations (1)

Research Site; 🇦🇱 Vlore, Albania