Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)
PHENIX
Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care
1 other identifier
observational
2,674
1 country
32
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 7, 2010
December 1, 2010
October 7, 2008
December 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms
Once, at first visit
Secondary Outcomes (3)
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
Eligibility Criteria
PPI-treated patients consulting with persistent GERD symptoms in Primary Care. The patients must have a diagnosis of GERD with predominant typical GERD symptoms and fail to obtain satisfactory symptomatic response after the first full course of standard dose PPI. The patients must have been on continuous PPI treatment with unchanged doses according to local labelling during the last 4-8 weeks prior to the enrolment visit.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Bjelovar, Croatia
Research Site
Bulinec, Croatia
Research Site
Crikvenica, Croatia
Research Site
Daruvar, Croatia
Research Site
Delnice, Croatia
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Garešnica, Croatia
Research Site
Gospić, Croatia
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Ivanec, Croatia
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Kalnik, Croatia
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Karlovac, Croatia
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Konjšćina, Croatia
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Koprivnica, Croatia
Research Site
Krapina, Croatia
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Lovran, Croatia
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Ludbreg, Croatia
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Nedelišće, Croatia
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Opatija, Croatia
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OriovacGornja Vrba, Croatia
Research Site
OtokPrivlakaIlokVukovarRetkovciGunjGarcin, Croatia
Research Site
Pregrada, Croatia
Research Site
PulaPorecPazinLabinRovinj, Croatia
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Rijeka, Croatia
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Samobor, Croatia
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SenjVodiceTrogirSinjImotskiMokosicaPloceMetkovic, Croatia
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Sisak, Croatia
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SlavonskibrodOsijekVisnjevacKoskaDonji miholjacPleternicaVelik, Croatia
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VarazdinCakovec, Croatia
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Virje, Croatia
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Zabok, Croatia
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ZadarSibenikDubrovnik, Croatia
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Zagreb, Croatia
Research Site
Zlatar, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
September 1, 2008
Study Completion
February 1, 2009
Last Updated
December 7, 2010
Record last verified: 2010-12