Clinical trial NCT01215305: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease, extraesophageal symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with upper GI symptoms

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.


Eligibility criteria: 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

Primary outcomes:
measure: GerdQ score
timeFrame: End of recruitment (estimated timeframe :2.5 months)
Secondary outcomes:
measure: Demographic data (age, gender, race, weight, height)
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Marital status
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Smoking habits, alcohol consumption
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Patient's eating habits and implementation of dietary recommendations
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Place of residence (urban, suburban, rural)
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Education level
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Occupation
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: General medical history
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: History of upper gastrointestinal diseases
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Compliance to antisecretory treatment (if applicable)
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Upper GI symptomatology XQS score
timeFrame: End of recruitment (estimated timeframe :2.5 months)
Other outcomes:
Locations:
city: Rodos
country: Greece
facility: Research Site
state: Dodekanis
city: Ioannina
country: Greece
facility: Research Site
state: Ipiros
city: Preveza
country: Greece
facility: Research Site
state: Ipiros
city: Chania
country: Greece
facility: Research Site
state: Kriti
city: Syros
country: Greece
facility: Research Site
state: Kyklades
city: Chalkidiki
country: Greece
facility: Research Site
state: Makedonia
city: Edessa
country: Greece
facility: Research Site
state: Makedonia
city: Kavala
country: Greece
facility: Research Site
state: Makedonia
city: Seres
country: Greece
facility: Research Site
state: Makedonia
city: Limnos
country: Greece
facility: Research Site
state: NE Aegian
city: Kalamata
country: Greece
facility: Research Site
state: Peloponisos
city: Kalavryta
country: Greece
facility: Research Site
state: Peloponisos
city: Molaoi
country: Greece
facility: Research Site
state: Peloponisos
city: Sparti
country: Greece
facility: Research Site
state: Peloponisos
city: Karditsa
country: Greece
facility: Research Site
state: Thesalia
city: Larisa
country: Greece
facility: Research Site
state: Thesalia
city: Trikala
country: Greece
facility: Research Site
state: Thesalia
city: Volos
country: Greece
facility: Research Site
state: Thesalia
city: Komotini
country: Greece
facility: Research Site
state: Thraki
Study officials:
affiliation: AstraZeneca
name: Panagiotis Pontikis
role: STUDY_DIRECTOR
References: