Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study

This study is currently recruiting participants.

Verified by AstraZeneca, December 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00697008

Purpose

To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.

Condition
GERD

MedlinePlus related topics: GERD

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Symptomatic outcome of GERD management following new guideline [ Time Frame: End of study visit 4-8w ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the frequency and type of extraesophageal and dyspeptic symptoms and their impact on the clinical outcome [ Time Frame: End of study 4-8w ] [ Designated as safety issue: No ]
To evaluate the impact of GERD symptoms in HRQoL [ Time Frame: End of study 4-8w ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
GERD patients Patients with typical GERD symptoms

Eligibility

Study Population

Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697008

Contacts

Contact: AstraZeneca Spain Clinical Study Information

349-130-100

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:

Javier Zapardiel, MD

AZ SPAIN

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager )
Study ID Numbers:	NIS-GES-DUM-2007/3
Study First Received:	June 4, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00697008
Health Authority:	Spain: Ethics Committee

Keywords provided by AstraZeneca:

GERD
CLINICAL GUIDELINE
Symptoms
clinical outcome

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