Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT00768443
- Lead Sponsor
- AstraZeneca
- Brief Summary
This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2674
Inclusion Criteria
- Provision of informed consent
- Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation
- Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day)
Exclusion Criteria
- Inability to read and/or understand Patient Reported Outcomes questionnaires
- Subjects where the only reason for the visit is renewing the prescription
- A history of an incomplete response to PPI treatment prior to current course of treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms Once, at first visit
- Secondary Outcome Measures
Name Time Method To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load Once, at first visit To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit Once, at first visit To describe the impact of persistent GERD symptoms on work productivity Once, at first visit
Trial Locations
- Locations (1)
Research Site
ðŸ‡ðŸ‡·Zlatar, Croatia