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Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ (GerdQ-Greece)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914342
First Posted: June 5, 2009
Last Update Posted: December 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.

Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study on the Prevalence and Impact in Work Productivity of GERD in Primary Care Patients With Upper GI Symptoms Using the Novel Questionnaire GERD-Q. The Greek GERD-Q Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8). [ Time Frame: Single Visit - once ]

Secondary Outcome Measures:
  • Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ) [ Time Frame: Single Visit - Once ]
  • Describe the impact of GERD symptoms on work productivity. [ Time Frame: Single Visit - Once ]
  • To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. [ Time Frame: Single Visit - Once ]

Enrollment: 889
Study Start Date: July 2009
Study Completion Date: December 2009
Groups/Cohorts
Upper-GI symptoms in primary-care patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who consult their primary care physician and have experienced upper-GI symptoms during the last week prior their consultation
Criteria

Inclusion Criteria:

  • Patients with upper-GI symptoms the last week prior visiting the investigator

Exclusion Criteria:

  • History of oesophageal, gastric or duodenal surgery
  • Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
  • PPI use for healing of NSAIDs induced ulcer or for HP eradication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914342


  Show 54 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Theodoros Rokkas, Dr Henry Dynan Hospital, Athens, Greece
Study Director: Panagiotis Pontikis, Dr AstraZeneca Greece
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00914342     History of Changes
Other Study ID Numbers: NIS-GGR-DUM-2009/1
First Submitted: June 3, 2009
First Posted: June 5, 2009
Last Update Posted: December 29, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Gerd
GerdQ questionnaire
work productivity
Greece

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases