Clinical trial NCT00914342: Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gerd
GerdQ questionnaire
work productivity
Greece
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 889
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief 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.


Eligibility 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

Primary outcomes:
measure: GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).
timeFrame: Single Visit - once
Secondary outcomes:
measure: 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)
timeFrame: Single Visit - Once
measure: Describe the impact of GERD symptoms on work productivity.
timeFrame: Single Visit - Once
measure: To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.
timeFrame: Single Visit - Once
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Research Site
state: Achaias
city: Mesologgion
country: Greece
facility: Research Site
state: Aitoloakarnaniaia
city: Naupaktos
country: Greece
facility: Research Site
state: Aitoloakarnaniaia
city: Grinion
country: Greece
facility: Research Site
state: Aitoloakarnania
city: Tripoli
country: Greece
facility: Research Site
state: Arkadias
city: Acharnes
country: Greece
facility: Research Site
state: Attiki
city: Ag.Eleutherios
country: Greece
facility: Research Site
state: Attiki
city: Ag.Paraskeui
country: Greece
facility: Research Site
state: Attiki
city: Athens
country: Greece
facility: Research Site
state: Attiki
city: Chalandri
country: Greece
facility: Research Site
state: Attiki
city: Galatsi
country: Greece
facility: Research Site
state: Attiki
city: Glifada
country: Greece
facility: Research Site
state: Attiki
city: Ilipoli
country: Greece
facility: Research Site
state: Attiki
city: Kallithea
country: Greece
facility: Research Site
state: Attiki
city: Keratea
country: Greece
facility: Research Site
state: Attiki
city: Loutsa
country: Greece
facility: Research Site
state: Attiki
city: Marousi
country: Greece
facility: Research Site
state: Attiki
city: N Makri
country: Greece
facility: Research Site
state: Attiki
city: N Smirni
country: Greece
facility: Research Site
state: Attiki
city: N.Herakeleios
country: Greece
facility: Research Site
state: Attiki
city: Peristeri
country: Greece
facility: Research Site
state: Attiki
city: Pikermi
country: Greece
facility: Research Site
state: Attiki
city: Pikerni
country: Greece
facility: Research Site
state: Attiki
city: Spata
country: Greece
facility: Research Site
state: Attiki
city: Mykonos
country: Greece
facility: Research Site
state: Cyclades
city: Santorini
country: Greece
facility: Research Site
state: Cyclades
city: Zante
country: Greece
facility: Research Site
state: Eptanisa
city: Lamia
country: Greece
facility: Research Site
state: Ftiotida
city: Lexena
country: Greece
facility: Research Site
state: Ilias
city: Veroia
country: Greece
facility: Research Site
state: Imathias
city: Chrisoupoli
country: Greece
facility: Research Site
state: Kavala
city: Volos
country: Greece
facility: Research Site
state: Magnisia
city: Kalamata
country: Greece
facility: Research Site
state: Mesinia
city: Giannitsa
country: Greece
facility: Research Site
state: Pella
city: Aleksandroupoli
country: Greece
facility: Research Site
city: Chalkida
country: Greece
facility: Research Site
city: Chalkidiki
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Corinth
country: Greece
facility: Research Site
city: Drama
country: Greece
facility: Research Site
city: Herakleion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Karditsa
country: Greece
facility: Research Site
city: Kastoria
country: Greece
facility: Research Site
city: Katerini
country: Greece
facility: Research Site
city: Komotini
country: Greece
facility: Research Site
city: Lakonia
country: Greece
facility: Research Site
city: Larrisa
country: Greece
facility: Research Site
city: Pereus
country: Greece
facility: Research Site
city: Ptolemaida
country: Greece
facility: Research Site
city: Salonika
country: Greece
facility: Research Site
city: Serres
country: Greece
facility: Research Site
city: Trikala
country: Greece
facility: Research Site
city: Xanthi
country: Greece
facility: Research Site
Study officials:
affiliation: Henry Dynan Hospital, Athens, Greece
name: Theodoros Rokkas, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Greece
name: Panagiotis Pontikis, Dr
role: STUDY_DIRECTOR
References: