Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ (GerdQ-Greece)

December 24, 2009 updated by: AstraZeneca

A Cross-sectional Study on the Prevalence and Impact in Work Productivity of GERD in Primary Care Patients With Upper GI Symptoms Using the Novel Questionnaire GERD-Q. The Greek GERD-Q Study

The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

889

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

  • Greece
      • Aleksandroupoli, Greece
        • Research Site
      • Chalkida, Greece
        • Research Site
      • Chalkidiki, Greece
        • Research Site
      • Chania, Greece
        • Research Site
      • Corinth, Greece
        • Research Site
      • Drama, Greece
        • Research Site
      • Herakleion, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Karditsa, Greece
        • Research Site
      • Kastoria, Greece
        • Research Site
      • Katerini, Greece
        • Research Site
      • Komotini, Greece
        • Research Site
      • Lakonia, Greece
        • Research Site
      • Larrisa, Greece
        • Research Site
      • Pereus, Greece
        • Research Site
      • Ptolemaida, Greece
        • Research Site
      • Salonika, Greece
        • Research Site
      • Serres, Greece
        • Research Site
      • Trikala, Greece
        • Research Site
      • Xanthi, Greece
        • Research Site
    • Achaias
      • Patras, Achaias, Greece
        • Research Site
    • Aitoloakarnania
      • Grinion, Aitoloakarnania, Greece
        • Research Site
    • Aitoloakarnaniaia
      • Mesologgion, Aitoloakarnaniaia, Greece
        • Research Site
      • Naupaktos, Aitoloakarnaniaia, Greece
        • Research Site
    • Arkadias
      • Tripoli, Arkadias, Greece
        • Research Site
    • Attiki
      • Acharnes, Attiki, Greece
        • Research Site
      • Ag.Eleutherios, Attiki, Greece
        • Research Site
      • Ag.Paraskeui, Attiki, Greece
        • Research Site
      • Athens, Attiki, Greece
        • Research Site
      • Chalandri, Attiki, Greece
        • Research Site
      • Galatsi, Attiki, Greece
        • Research Site
      • Glifada, Attiki, Greece
        • Research Site
      • Ilipoli, Attiki, Greece
        • Research Site
      • Kallithea, Attiki, Greece
        • Research Site
      • Keratea, Attiki, Greece
        • Research Site
      • Loutsa, Attiki, Greece
        • Research Site
      • Marousi, Attiki, Greece
        • Research Site
      • N Makri, Attiki, Greece
        • Research Site
      • N Smirni, Attiki, Greece
        • Research Site
      • N.Herakeleios, Attiki, Greece
        • Research Site
      • Peristeri, Attiki, Greece
        • Research Site
      • Pikermi, Attiki, Greece
        • Research Site
      • Pikerni, Attiki, Greece
        • Research Site
      • Spata, Attiki, Greece
        • Research Site
    • Cyclades
      • Mykonos, Cyclades, Greece
        • Research Site
      • Santorini, Cyclades, Greece
        • Research Site
    • Eptanisa
      • Zante, Eptanisa, Greece
        • Research Site
    • Ftiotida
      • Lamia, Ftiotida, Greece
        • Research Site
    • Ilias
      • Lexena, Ilias, Greece
        • Research Site
    • Imathias
      • Veroia, Imathias, Greece
        • Research Site
    • Kavala
      • Chrisoupoli, Kavala, Greece
        • Research Site
    • Magnisia
      • Volos, Magnisia, Greece
        • Research Site
    • Mesinia
      • Kalamata, Mesinia, Greece
        • Research Site
    • Pella
      • Giannitsa, Pella, Greece
        • 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

Patients who consult their primary care physician and have experienced upper-GI symptoms during the last week prior their consultation

Description

Inclusion Criteria:

  • Patients with upper-GI symptoms the last week prior visiting the investigator

Exclusion Criteria:

  • History of oesophageal, gastric or duodenal surgery
  • Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
  • PPI use for healing of NSAIDs induced ulcer or for HP eradication

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
Upper-GI symptoms in primary-care patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).
Time Frame: Single Visit - once
Single Visit - once

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ)
Time Frame: Single Visit - Once
Single Visit - Once
Describe the impact of GERD symptoms on work productivity.
Time Frame: Single Visit - Once
Single Visit - Once
To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.
Time Frame: Single Visit - Once
Single Visit - Once

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Theodoros Rokkas, Dr, Henry Dynan Hospital, Athens, Greece
  • Study Director: Panagiotis Pontikis, Dr, AstraZeneca Greece

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

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Estimate)

December 29, 2009

Last Update Submitted That Met QC Criteria

December 24, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GGR-DUM-2009/1

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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