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
1 other identifier
observational
600
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 6, 2011
April 1, 2011
5 months
October 5, 2010
April 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GerdQ score
End of recruitment (estimated timeframe :2.5 months)
Secondary Outcomes (12)
Demographic data (age, gender, race, weight, height)
End of recruitment (estimated timeframe :2.5 months)
Marital status
End of recruitment (estimated timeframe :2.5 months)
Smoking habits, alcohol consumption
End of recruitment (estimated timeframe :2.5 months)
Patient's eating habits and implementation of dietary recommendations
End of recruitment (estimated timeframe :2.5 months)
Place of residence (urban, suburban, rural)
End of recruitment (estimated timeframe :2.5 months)
- +7 more secondary outcomes
Study Arms (1)
Visiting outpatient departments, if symtoms
patients with upper GI symptoms, visiting the outpatient departments of peripheral hospitals in Greece
Eligibility Criteria
Patients with upper GI symptoms
You may qualify if:
- Provision of written informed consent
- Patients aged 18 and over
- Patients with upper-GI symptoms during the last week prior to the study visit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Chania, Crete, Greece
Research Site
Rhodes, Dodekanis, Greece
Research Site
Ioannina, Ipiros, Greece
Research Site
Preveza, Ipiros, Greece
Research Site
Áno Sýros, Kyklades, Greece
Research Site
Chalkidiki, Makedonia, Greece
Research Site
Edessa, Makedonia, Greece
Research Site
Kavala, Makedonia, Greece
Research Site
Serres, Makedonia, Greece
Research Site
Limnos, NE Aegian, Greece
Research Site
Kalamata, Peloponisos, Greece
Research Site
Kalávryta, Peloponisos, Greece
Research Site
Moláoi, Peloponisos, Greece
Research Site
Sparti, Peloponisos, Greece
Research Site
Karditsa, Thesalia, Greece
Research Site
Larissa, Thesalia, Greece
Research Site
Trikala, Thesalia, Greece
Research Site
Volos, Thesalia, Greece
Research Site
Komotini, Thraki, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Panagiotis Pontikis
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 6, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 6, 2011
Record last verified: 2011-04