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NCT Number: 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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Chania, Crete, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GerdQ score

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

Secondary outcomes

  1. Demographic data (age, gender, race, weight, height)

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

  2. Marital status

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

  3. Smoking habits, alcohol consumption

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

  4. Patient's eating habits and implementation of dietary recommendations

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

  5. Place of residence (urban, suburban, rural)

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

  6. Education level

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

  7. Occupation

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

  8. General medical history

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

  9. History of upper gastrointestinal diseases

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

  10. Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)

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

  11. Compliance to antisecretory treatment (if applicable)

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

  12. Upper GI symptomatology XQS score

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: GERDQ-XS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2010
Registry last updated
Apr 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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