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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00697008
First received: June 4, 2008
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

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


Condition
GERD

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
GERD patients
Patients with typical GERD symptoms

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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

Criteria

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

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

No publications provided

Responsible Party: Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00697008     History of Changes
Other Study ID Numbers: NIS-GES-DUM-2007/3
Study First Received: June 4, 2008
Last Updated: February 9, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
GERD
CLINICAL GUIDELINE
Symptoms
clinical outcome

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

ClinicalTrials.gov processed this record on April 21, 2014