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

Gastroesophageal Reflux Disease Clinical Trial

— GERDQ-XS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215305
• Other study ID #: NIS-GGR-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: April 5, 2011
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Greece	Research Site	Chalkidiki	Makedonia
Greece	Research Site	Chania	Kriti
Greece	Research Site	Edessa	Makedonia
Greece	Research Site	Ioannina	Ipiros
Greece	Research Site	Kalamata	Peloponisos
Greece	Research Site	Kalavryta	Peloponisos
Greece	Research Site	Karditsa	Thesalia
Greece	Research Site	Kavala	Makedonia
Greece	Research Site	Komotini	Thraki
Greece	Research Site	Larisa	Thesalia
Greece	Research Site	Limnos	NE Aegian
Greece	Research Site	Molaoi	Peloponisos
Greece	Research Site	Preveza	Ipiros
Greece	Research Site	Rodos	Dodekanis
Greece	Research Site	Seres	Makedonia
Greece	Research Site	Sparti	Peloponisos
Greece	Research Site	Syros	Kyklades
Greece	Research Site	Trikala	Thesalia
Greece	Research Site	Volos	Thesalia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GerdQ score		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Demographic data (age, gender, race, weight, height)		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Marital status		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Smoking habits, alcohol consumption		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Patient's eating habits and implementation of dietary recommendations		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Place of residence (urban, suburban, rural)		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Education level		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Occupation		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	General medical history		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	History of upper gastrointestinal diseases		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Compliance to antisecretory treatment (if applicable)		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Upper GI symptomatology XQS score		End of recruitment (estimated timeframe :2.5 months)	No