A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of Gastroesophageal Reflux Disease(GERD) in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece (GERDQ-XS)

April 5, 2011 updated by: AstraZeneca

A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of GERD in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece. The 'GERDQ-XS' Study

The present study has been designed to provide current data on GERD prevalence in several regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to measure the treatment response in GERD patients, and to assess the correlations between the two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The XQS questionnaire will be applied for the identification of these patients and the assessment of the extraesophageal disease burden (frequency and intensity/severity). Finally, an association between the GerdQ and XQS scores will be attempted.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

600

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
    • Dodekanis
      • Rodos, Dodekanis, Greece
        • Research Site
    • Ipiros
      • Ioannina, Ipiros, Greece
        • Research Site
      • Preveza, Ipiros, Greece
        • Research Site
    • Kriti
      • Chania, Kriti, Greece
        • Research Site
    • Kyklades
      • Syros, Kyklades, Greece
        • Research Site
    • Makedonia
      • Chalkidiki, Makedonia, Greece
        • Research Site
      • Edessa, Makedonia, Greece
        • Research Site
      • Kavala, Makedonia, Greece
        • Research Site
      • Seres, Makedonia, Greece
        • Research Site
    • NE Aegian
      • Limnos, NE Aegian, Greece
        • Research Site
    • Peloponisos
      • Kalamata, Peloponisos, Greece
        • Research Site
      • Kalavryta, Peloponisos, Greece
        • Research Site
      • Molaoi, Peloponisos, Greece
        • Research Site
      • Sparti, Peloponisos, Greece
        • Research Site
    • Thesalia
      • Karditsa, Thesalia, Greece
        • Research Site
      • Larisa, Thesalia, Greece
        • Research Site
      • Trikala, Thesalia, Greece
        • Research Site
      • Volos, Thesalia, Greece
        • Research Site
    • Thraki
      • Komotini, Thraki, 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 with upper GI symptoms

Description

Inclusion Criteria:

  • Provision of written informed consent
  • Patients aged 18 and over
  • Patients with upper-GI symptoms during the last week prior to the study visit

Exclusion Criteria:

  • History of oesophageal, gastric or duodenal surgery
  • Patients with history of malignancy
  • Treatment with acetylsalicylic acid/NSAID during the last week prior to the study visit
  • Therapy with PPI for the healing of ulcer induced by treatment with acetylsalicylic acid/NSAID
  • Therapy with PPI for HP eradication or for healing of HP-related peptic ulcer

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Visiting outpatient departments, if symtoms
patients with upper GI symptoms, visiting the outpatient departments of peripheral hospitals in Greece

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GerdQ score
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic data (age, gender, race, weight, height)
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Marital status
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Smoking habits, alcohol consumption
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Patient's eating habits and implementation of dietary recommendations
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Place of residence (urban, suburban, rural)
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Education level
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Occupation
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
General medical history
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
History of upper gastrointestinal diseases
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Compliance to antisecretory treatment (if applicable)
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Upper GI symptomatology XQS score
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Panagiotis Pontikis, AstraZeneca

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

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GGR-DUM-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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