Clinical trial NCT00768443: Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)
Official title: Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
PPI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 2674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PPI-treated patients consulting with persistent GERD symptoms in Primary Care. The patients must have a diagnosis of GERD with predominant typical GERD symptoms and fail to obtain satisfactory symptomatic response after the first full course of standard dose PPI. The patients must have been on continuous PPI treatment with unchanged doses according to local labelling during the last 4-8 weeks prior to the enrolment visit.

Brief summary: This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation
* Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day)

Exclusion Criteria:

* Inability to read and/or understand Patient Reported Outcomes questionnaires
* Subjects where the only reason for the visit is renewing the prescription
* A history of an incomplete response to PPI treatment prior to current course of treatment

Primary outcomes:
measure: To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
timeFrame: Once, at first visit
Secondary outcomes:
measure: To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load
timeFrame: Once, at first visit
measure: To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit
timeFrame: Once, at first visit
measure: To describe the impact of persistent GERD symptoms on work productivity
timeFrame: Once, at first visit
Other outcomes:
Locations:
city: Bjelovar
country: Croatia
facility: Research Site
city: Bulinec
country: Croatia
facility: Research Site
city: Crikvenica
country: Croatia
facility: Research Site
city: Daruvar
country: Croatia
facility: Research Site
city: Delnice
country: Croatia
facility: Research Site
city: Garesnica
country: Croatia
facility: Research Site
city: Gospic
country: Croatia
facility: Research Site
city: Ivanec
country: Croatia
facility: Research Site
city: Kalnik
country: Croatia
facility: Research Site
city: Karlovac
country: Croatia
facility: Research Site
city: Konjscina
country: Croatia
facility: Research Site
city: Koprivnica
country: Croatia
facility: Research Site
city: Krapina
country: Croatia
facility: Research Site
city: Lovran
country: Croatia
facility: Research Site
city: Ludbreg
country: Croatia
facility: Research Site
city: Nedelisce
country: Croatia
facility: Research Site
city: Opatija
country: Croatia
facility: Research Site
city: OriovacGornja Vrba
country: Croatia
facility: Research Site
city: OtokPrivlakaIlokVukovarRetkovciGunjGarcin
country: Croatia
facility: Research Site
city: Pregrada
country: Croatia
facility: Research Site
city: PulaPorecPazinLabinRovinj
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Samobor
country: Croatia
facility: Research Site
city: SenjVodiceTrogirSinjImotskiMokosicaPloceMetkovic
country: Croatia
facility: Research Site
city: Sisak
country: Croatia
facility: Research Site
city: SlavonskibrodOsijekVisnjevacKoskaDonji miholjacPleternicaVelik
country: Croatia
facility: Research Site
city: VarazdinCakovec
country: Croatia
facility: Research Site
city: Virje
country: Croatia
facility: Research Site
city: Zabok
country: Croatia
facility: Research Site
city: ZadarSibenikDubrovnik
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Zlatar
country: Croatia
facility: Research Site
Study officials:
References: