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CompletedNCT01215305GERDQ-XSUpdated Apr 6, 2011

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

An observational study in Gastroesophageal Reflux Disease, sponsored by AstraZeneca. Completed at 19 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-06.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Gastroesophageal Reflux Disease

Keywords

  • Gastroesophageal Reflux Disease, extraesophageal symptoms
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 600 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with upper GI symptoms

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (actual)

Groups and cohorts

  • Visiting outpatient departments, if symtoms

    patients with upper GI symptoms, visiting the outpatient departments of peripheral hospitals in Greece

06

What researchers measure

Primary outcomes

  1. GerdQ score

    Time frame: End of recruitment (estimated timeframe :2.5 months)

Secondary outcomes

  1. Demographic data (age, gender, race, weight, height)

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  2. Marital status

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  3. Smoking habits, alcohol consumption

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  4. Patient's eating habits and implementation of dietary recommendations

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  5. Place of residence (urban, suburban, rural)

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  6. Education level

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  7. Occupation

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  8. General medical history

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  9. History of upper gastrointestinal diseases

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  10. 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)

  11. Compliance to antisecretory treatment (if applicable)

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  12. Upper GI symptomatology XQS score

    Time frame: End of recruitment (estimated timeframe :2.5 months)

07

Study locations

19 sites
  • Research Site
    Rodos, Dodekanis, Greece
  • Research Site
    Ioannina, Ipiros, Greece
  • Research Site
    Preveza, Ipiros, Greece
  • Research Site
    Chania, Kriti, Greece
  • Research Site
    Syros, Kyklades, Greece
  • Research Site
    Chalkidiki, Makedonia, Greece
  • Research Site
    Edessa, Makedonia, Greece
  • Research Site
    Kavala, Makedonia, Greece
  • Research Site
    Seres, Makedonia, Greece
  • Research Site
    Limnos, NE Aegian, Greece
  • Research Site
    Kalamata, Peloponisos, Greece
  • Research Site
    Kalavryta, Peloponisos, Greece
  • Research Site
    Molaoi, Peloponisos, Greece
  • Research Site
    Sparti, Peloponisos, Greece
  • Research Site
    Karditsa, Thesalia, Greece
  • Research Site
    Larisa, Thesalia, Greece
  • Research Site
    Trikala, Thesalia, Greece
  • Research Site
    Volos, Thesalia, Greece
  • Research Site
    Komotini, Thraki, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01215305
Lead sponsor
AstraZeneca
First posted
Oct 6, 2010
Start date
Oct 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Apr 6, 2011

Study contacts

Panagiotis Pontikis
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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