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

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT01215305
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-05
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GerdQ score	End of recruitment (estimated timeframe :2.5 months)

Secondary Outcome Measures

Name	Time	Method
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)
Education level	End of recruitment (estimated timeframe :2.5 months)
Occupation	End of recruitment (estimated timeframe :2.5 months)
General medical history	End of recruitment (estimated timeframe :2.5 months)
History of upper gastrointestinal diseases	End of recruitment (estimated timeframe :2.5 months)
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)
Compliance to antisecretory treatment (if applicable)	End of recruitment (estimated timeframe :2.5 months)
Upper GI symptomatology XQS score	End of recruitment (estimated timeframe :2.5 months)

Trial Locations

Locations (1)

Research Site; 🇬🇷 Komotini, Thraki, Greece