Clinical trial NCT01200550: The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients
Official title: An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
GERD Impact Scale
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 1233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treted with proton pump inhibitors, for whom GP or specialist (in primary care unit) have previosly decided to initiate or change treatment for GERD.

Brief summary: The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.


Eligibility criteria: Inclusion Criteria:

* Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice

Exclusion Criteria:

* Females of childbearing potential should not be pregnant or nursing

Primary outcomes:
measure: Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
timeFrame: Maximum of 14 weeks, with 3 visits in total
measure: Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
timeFrame: Visit 1 (enrolment)
measure: Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
timeFrame: Visit 2 (4-6 weeks after Visit 1)
measure: Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
timeFrame: Visit 3 (8-14 weeks after Visit 1).
Secondary outcomes:
measure: The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients
timeFrame: Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1).
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Research Site
city: Bijeljina
country: Bosnia and Herzegovina
facility: Research Site
city: Derventa
country: Bosnia and Herzegovina
facility: Research Site
city: Doboj
country: Bosnia and Herzegovina
facility: Research Site
city: Gracanica
country: Bosnia and Herzegovina
facility: Research Site
city: Gradacac
country: Bosnia and Herzegovina
facility: Research Site
city: Gradiska
country: Bosnia and Herzegovina
facility: Research Site
city: Hadzici
country: Bosnia and Herzegovina
facility: Research Site
city: Jelah
country: Bosnia and Herzegovina
facility: Research Site
city: Laktasi
country: Bosnia and Herzegovina
facility: Research Site
city: Lukavac
country: Bosnia and Herzegovina
facility: Research Site
city: Lukavica
country: Bosnia and Herzegovina
facility: Research Site
city: Matuzici
country: Bosnia and Herzegovina
facility: Research Site
city: Mostar
country: Bosnia and Herzegovina
facility: Research Site
city: Pale
country: Bosnia and Herzegovina
facility: Research Site
city: Prijedor
country: Bosnia and Herzegovina
facility: Research Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Research Site
city: Trn
country: Bosnia and Herzegovina
facility: Research Site
city: Tuzla
country: Bosnia and Herzegovina
facility: Research Site
city: Visoko
country: Bosnia and Herzegovina
facility: Research Site
city: Vogosca
country: Bosnia and Herzegovina
facility: Research Site
city: Zaluzani
country: Bosnia and Herzegovina
facility: Research Site
city: Zivinice
country: Bosnia and Herzegovina
facility: Research Site
Study officials:
affiliation: Clinical Center University of Sarajevo; Department of Gastrenterology and HepatologySarajevo
name: Srdjan Gornjakovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: