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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697008
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : February 10, 2009
Information provided by:

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

Condition or disease

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptomatic Assessment and Therapeutic Outcomes in Typical GERD Patients Following a New CP Guideline in the Clinical Practice
Study Start Date : December 2007
Actual Primary Completion Date : January 2009

GERD patients
Patients with typical GERD symptoms

Primary Outcome Measures :
  1. Symptomatic outcome of GERD management following new guideline [ Time Frame: End of study visit 4-8w ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the impact of GERD symptoms in HRQoL [ Time Frame: End of study 4-8w ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with typical GERD symptoms consulting in specialized care setting and are managed following the new local GERD guidelines

Inclusion Criteria:

  • Signed informed consent
  • Age above 18
  • Subjects with typical GERD symptoms: predominant heartburn/regurgitation
  • Naive patients or off PPI treatment in the last 2 months

Exclusion Criteria:

  • Inability to read and understand PRO instructions
  • Patient not suitable to be treated following the AEG guidelines
  • Concomitant treatment with NSAID, antiplatelet drugs
  • Previous PPI failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697008

Research Site
Oviedo, Asturias, Spain
Research Site
Palma de Mallorca, Baleares, Spain
Research Site
Sabadell, Barcelona, Spain
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Viladecans, Barcelona, Spain
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Jerez de La Frontera, Cadiz, Spain
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Cabra, Cordoba, Spain
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San Sebastian, Guipuzcoa, Spain
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A Coruna, La Coruna, Spain
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Santiago de Compostela, La Coru�a, Spain
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Marbella, Malaga, Spain
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Verin, Orense, Spain
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Vigo, Pontevedra, Spain
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La Cuesta de Arguijon, Tenerife, Spain
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Alzira, Valencia, Spain
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Baracaldo, Vizcaya, Spain
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Bilbao, Vizcaya, Spain
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Badajoz, Spain
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Barcelona, Spain
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Cadiz, Spain
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Cordoba, Spain
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Huelva, Spain
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Huesca, Spain
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Madrid, Spain
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Malaga, Spain
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Murcia, Spain
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Sevilla, Spain
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Tarragona, Spain
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Valencia, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
Study Chair: Javier Zapardiel, MD AZ SPAIN

Responsible Party: Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager, AstraZeneca Pharmaceuticals Identifier: NCT00697008     History of Changes
Other Study ID Numbers: NIS-GES-DUM-2007/3
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by AstraZeneca:
clinical outcome

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