Clinical trial NCT01134367: An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease
Official title: An Epidemiological, Postmarketing Observational Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease (GERD) on Patients' Daily Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: gastroesophageal reflux disease (GERD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinics

Brief summary: The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.


Eligibility criteria: Inclusion Criteria:

* Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre
* Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)

Primary outcomes:
measure: Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Typical GERD symptoms (indicating frequency and severity of symptoms) and signs
timeFrame: 8 weeks
measure: Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data
timeFrame: 8 weeks
measure: Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Treatments for GERD and treatment changes
timeFrame: 8 weeks
measure: Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Patient's perspective of symptom control and impact on daily life assessed using a patient-questionnaire (GIS-GERD Impact Scale).
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the added value of a patient questionnaire (GIS-GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Research Site
city: Leskovac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Pancevo
country: Serbia
facility: Research Site
city: Subotica
country: Serbia
facility: Research Site
city: Zrenjanin
country: Serbia
facility: Research Site
Study officials:
affiliation: Institute for Gastroenterology, Clinical Center of Serbia, Belgrade
name: Miodrag Krstić, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Internal Diseases, Clinical Center of Vojvodina, Novi Sad
name: Dragomir Damjanov, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Internal Diseases- Gastroenterology Dept, Clinical Center Nis
name: Aleksandar Nagorni, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: