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

February 23, 2011 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

491

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
      • Berat, Albania
        • Research Site
      • Burrel, Albania
        • Research Site
      • Durres, Albania
        • Research Site
      • Elbasan, Albania
        • Research Site
      • Fier, Albania
        • Research Site
      • Kavaje, Albania
        • Research Site
      • Korce, Albania
        • Research Site
      • Kruje, Albania
        • Research Site
      • Lezhe, Albania
        • Research Site
      • Lushnje, Albania
        • Research Site
      • Peshkopi, Albania
        • Research Site
      • Shkoder, Albania
        • Research Site
      • Tirane, Albania
        • Research Site
      • Vlore, Albania
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
Time Frame: Day 0
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
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
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
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
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
Weeks 2-4
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
Time Frame: Weeks 8-12
Weeks 8-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Karin Otter, MD, PhD, Medical Director BBC
  • Study Chair: Senka Riza, Medical and Regulatory Manager
  • Principal Investigator: Skerdi Prifti, Asc.Proff., University Hospital Center "Mother Teresa"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (ESTIMATE)

May 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-GAL-NEX-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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