The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients

N/ACompletedNCT01200550

AstraZeneca1,233 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,233

Conditions

Gastroesophageal Reflux Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Research Site

Banja Luka, Bosnia and Herzegovina

Research Site

Bijeljina, Bosnia and Herzegovina

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: Maximum of 14 weeks, with 3 visits in total

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 1 (enrolment)

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 2 (4-6 weeks after Visit 1)

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

Time frame: 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).

Data from ClinicalTrials.gov

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