Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00768443

Acronym

PHENIX

Enrollment

2674

Registered

2008-10-08

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD, PPI

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..

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms	Once, at first visit

Secondary

Measure	Time frame
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

Countries

Croatia

Outcome results