An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

AstraZeneca1 site in 1 country1,233 target enrollmentSeptember 2010

ConditionsGastroesophageal Reflux Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastroesophageal Reflux Disease
Sponsor: AstraZeneca
Enrollment: 1233
Locations: 1
Primary Endpoint: Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

November 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

Time Frame: Visit 3 (8-14 weeks after Visit 1).

Secondary Outcomes

The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients(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).)