Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care

AstraZeneca1 site in 1 country2,674 target enrollmentSeptember 2008

ConditionsGastroesophageal Reflux Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gastroesophageal Reflux Disease
Sponsor: AstraZeneca
Enrollment: 2674
Locations: 1
Primary Endpoint: To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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..

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

February 2009

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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)