Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease Clinical Trial

— PHENIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768443
• Other study ID #: NIS-GHR-NEX-2008/1
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: December 6, 2010
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Agency for Medicinal Product and Medical DevicesCroatia: Ethics Committee
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2674
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Croatia	Research Site	Bjelovar
Croatia	Research Site	Bulinec
Croatia	Research Site	Crikvenica
Croatia	Research Site	Daruvar
Croatia	Research Site	Delnice
Croatia	Research Site	Garesnica
Croatia	Research Site	Gospic
Croatia	Research Site	Ivanec
Croatia	Research Site	Kalnik
Croatia	Research Site	Karlovac
Croatia	Research Site	Konjscina
Croatia	Research Site	Koprivnica
Croatia	Research Site	Krapina
Croatia	Research Site	Lovran
Croatia	Research Site	Ludbreg
Croatia	Research Site	Nedelisce
Croatia	Research Site	Opatija
Croatia	Research Site	OriovacGornja Vrba
Croatia	Research Site	OtokPrivlakaIlokVukovarRetkovciGunjGarcin
Croatia	Research Site	Pregrada
Croatia	Research Site	PulaPorecPazinLabinRovinj
Croatia	Research Site	Rijeka
Croatia	Research Site	Samobor
Croatia	Research Site	SenjVodiceTrogirSinjImotskiMokosicaPloceMetkovic
Croatia	Research Site	Sisak
Croatia	Research Site	SlavonskibrodOsijekVisnjevacKoskaDonji miholjacPleternicaVelik
Croatia	Research Site	VarazdinCakovec
Croatia	Research Site	Virje
Croatia	Research Site	Zabok
Croatia	Research Site	ZadarSibenikDubrovnik
Croatia	Research Site	Zagreb
Croatia	Research Site	Zlatar

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms		Once, at first visit	No
Secondary	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
Secondary	To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit		Once, at first visit
Secondary	To describe the impact of persistent GERD symptoms on work productivity		Once, at first visit