Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD) (PHENIX)

December 6, 2010 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2674

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • 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, Croatia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Once, at first visit

Secondary Outcome Measures

Outcome 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
Time Frame: Once, at first visit
Once, at first visit
To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit
Time Frame: Once, at first visit
Once, at first visit
To describe the impact of persistent GERD symptoms on work productivity
Time Frame: Once, at first visit
Once, at first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GHR-NEX-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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