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Clinical Trials/NCT01215305
NCT01215305
Completed
Not Applicable

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

AstraZeneca1 site in 1 country600 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastroesophageal Reflux Disease
Sponsor
AstraZeneca
Enrollment
600
Locations
1
Primary Endpoint
GerdQ score
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
March 2011
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

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

Outcomes

Primary Outcomes

GerdQ score

Time Frame: End of recruitment (estimated timeframe :2.5 months)

Secondary Outcomes

  • 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))

Study Sites (1)

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