The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT01200550
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1233
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years Visit 3 (8-14 weeks after Visit 1).
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Research Site
🇧🇦Zivinice, Bosnia and Herzegovina