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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00768443
First received: October 7, 2008
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • To describe the impact of persistent GERD symptoms on work productivity [ Time Frame: Once, at first visit ]

Enrollment: 2674
Study Start Date: September 2008
Study Completion Date: February 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768443

Locations
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, Croatia
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00768443     History of Changes
Other Study ID Numbers: NIS-GHR-NEX-2008/1
Study First Received: October 7, 2008
Last Updated: December 6, 2010
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee

Keywords provided by AstraZeneca:
GERD
PPI

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 27, 2014