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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00914342
First received: June 3, 2009
Last updated: December 24, 2009
Last verified: December 2009
History of Changes
  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:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Describe the impact of GERD symptoms on work productivity. [ Time Frame: Single Visit - Once ] [ Designated as safety issue: No ]
  • To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. [ Time Frame: Single Visit - Once ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00914342     History of Changes
Other Study ID Numbers: NIS-GGR-DUM-2009/1
Study First Received: June 3, 2009
Last Updated: December 24, 2009
Health Authority: Greece: National Drug Organization (EOF)

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

ClinicalTrials.gov processed this record on May 19, 2013