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

NCT ID: NCT01215305

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Visiting outpatient departments, if symtoms

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca S.A. Greece

Principal Investigators

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Panagiotis Pontikis

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Chania, Crete, Greece

Site Status

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Rhodes, Dodekanis, Greece

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Ioannina, Ipiros, Greece

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Preveza, Ipiros, Greece

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Áno Sýros, Kyklades, Greece

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Chalkidiki, Makedonia, Greece

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Edessa, Makedonia, Greece

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Kavala, Makedonia, Greece

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Serres, Makedonia, Greece

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Limnos, NE Aegian, Greece

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Kalamata, Peloponisos, Greece

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Kalávryta, Peloponisos, Greece

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Moláoi, Peloponisos, Greece

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Sparti, Peloponisos, Greece

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Karditsa, Thesalia, Greece

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Larissa, Thesalia, Greece

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Trikala, Thesalia, Greece

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Volos, Thesalia, Greece

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Komotini, Thraki, Greece

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Countries

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Greece

Other Identifiers

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NIS-GGR-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id

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