NCT00768443CompletedNot Applicable
Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 2,674
- Locations
- 1
- Primary Endpoint
- To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Study Overview
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..
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Time Frame: Once, at first visit
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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