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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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