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

Gastroesophageal Reflux Disease Clinical Trial

— GerdQ-Greece  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914342
• Other study ID #: NIS-GGR-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: June 3, 2009
• Last updated: December 24, 2009
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Drug Organization (EOF)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 889
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Greece	Research Site	Acharnes	Attiki
Greece	Research Site	Ag.Eleutherios	Attiki
Greece	Research Site	Ag.Paraskeui	Attiki
Greece	Research Site	Aleksandroupoli
Greece	Research Site	Athens	Attiki
Greece	Research Site	Chalandri	Attiki
Greece	Research Site	Chalkida
Greece	Research Site	Chalkidiki
Greece	Research Site	Chania
Greece	Research Site	Chrisoupoli	Kavala
Greece	Research Site	Corinth
Greece	Research Site	Drama
Greece	Research Site	Galatsi	Attiki
Greece	Research Site	Giannitsa	Pella
Greece	Research Site	Glifada	Attiki
Greece	Research Site	Grinion	Aitoloakarnania
Greece	Research Site	Herakleion
Greece	Research Site	Ilipoli	Attiki
Greece	Research Site	Ioannina
Greece	Research Site	Kalamata	Mesinia
Greece	Research Site	Kallithea	Attiki
Greece	Research Site	Karditsa
Greece	Research Site	Kastoria
Greece	Research Site	Katerini
Greece	Research Site	Keratea	Attiki
Greece	Research Site	Komotini
Greece	Research Site	Lakonia
Greece	Research Site	Lamia	Ftiotida
Greece	Research Site	Larrisa
Greece	Research Site	Lexena	Ilias
Greece	Research Site	Loutsa	Attiki
Greece	Research Site	Marousi	Attiki
Greece	Research Site	Mesologgion	Aitoloakarnaniaia
Greece	Research Site	Mykonos	Cyclades
Greece	Research Site	N Makri	Attiki
Greece	Research Site	N Smirni	Attiki
Greece	Research Site	N.Herakeleios	Attiki
Greece	Research Site	Naupaktos	Aitoloakarnaniaia
Greece	Research Site	Patras	Achaias
Greece	Research Site	Pereus
Greece	Research Site	Peristeri	Attiki
Greece	Research Site	Pikermi	Attiki
Greece	Research Site	Pikerni	Attiki
Greece	Research Site	Ptolemaida
Greece	Research Site	Salonika
Greece	Research Site	Santorini	Cyclades
Greece	Research Site	Serres
Greece	Research Site	Spata	Attiki
Greece	Research Site	Trikala
Greece	Research Site	Tripoli	Arkadias
Greece	Research Site	Veroia	Imathias
Greece	Research Site	Volos	Magnisia
Greece	Research Site	Xanthi
Greece	Research Site	Zante	Eptanisa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).		Single Visit - once	No
Secondary	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)		Single Visit - Once	No
Secondary	Describe the impact of GERD symptoms on work productivity.		Single Visit - Once	No
Secondary	To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.		Single Visit - Once	No