Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00768443

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

MedlinePlus related topics: GERD

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	September 2008

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

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

Contacts

Contact: AstraZeneca Croatia Clinical Study Information

+385 1 4628 002

anamarija.gjurovic@astrazeneca.com

Locations

Croatia
Research Site	Recruiting
Bjelovar, Croatia
Research Site	Recruiting
Bulinec, Croatia
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Crikvenica, Croatia
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Daruvar, Croatia
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Delnice, Croatia
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Garesnica, Croatia
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Gospic, Croatia
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Ivanec, Croatia
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Kalnik, Croatia
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Karlovac, Croatia
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Konjscina, Croatia
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Koprivnica, Croatia
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Krapina, Croatia
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Lovran, Croatia
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Ludbreg, Croatia
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Nedelisce, Croatia
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Zlatar, Croatia
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OriovacGornja Vrba, Croatia
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OtokPrivlakaIlokVukovarRetkovciGunjGarcin, Croatia
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Pregrada, Croatia
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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
Research Site	Recruiting
Zagreb, Croatia
Research Site	Recruiting
Opatija, Croatia

Sponsors and Collaborators

AstraZeneca

More Information

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

Keywords provided by AstraZeneca:

GERD
PPI

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 15, 2009